Clinical Research Directory

Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases

Background: Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why. Objective: To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2. Eligibility: Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection. Design: Participants will be screened with a medical history and blood and urine tests. Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health. After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH. This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines. ...

Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients

The purpose of this study is to compare the immunogenicity and safety of respiratory syncytial virus (RSV) vaccination between lung transplant recipients and immunocompetent adults and to provide evidence to guide RSV vaccination in lung transplant recipients.

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Influenza is an important pathogen in transplant recipients. The current widespread outbreak of highly pathogenic H5N1 avian influenza (HPAI) in livestock, and the occurrence of several human cases of infection suggest that the next influenza pandemic may be soon approaching. Transplant patients will likely be uniquely predisposed to serious infection with high morbidity and mortality. There are a number of important reasons that evaluation of prevention strategies are critical in this highly vulnerable population. Currently, there is no data on the immunogenicity of H5Nx vaccines in this highly vulnerable population. The investigators plan to study the safety and immunogenicity of a two-dose regimen of the pandemic influenza H5N1 vaccine in organ transplant patients.

Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system. Families will have their child keep their regular sleep schedule during the 5-week study. They will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice for 1 - 1 ½ hours. During the first visit, the child get the vaccine. During the second, they have a blood test.

Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children

In this proposed study, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection/vaccination) to help manage pediatric pain. The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in condition (e.g., pain relief) after using an inert substance (e.g., a placebo analgesic). This effect is primarily attributed to expectations about the placebo's effectiveness. The investigators extend this line of research by demonstrating that, under certain circumstances, merely possessing a placebo can also lead to pain relief. This possession-based placebo analgesic effect arises from a sense of ownership, which enhances the expectation that the owned placebo can provide benefits to the self. This study expands the scope of the possession-based placebo effect by examining its applicability in a real-life situation - the investigators expect that providing children with ownership of a first-aid bandage before vaccination will improve the overall pain experience. Focusing on children's pain is critical for several reasons. First, pain is a common experience for children, who are often less mature and independent than adults in assessing and managing it. This renders children a vulnerable population requiring improved pain management interventions. Unfortunately, pediatric pain recognition and treatment are still inadequate. Second, most past placebo analgesic studies have focused on adults, leading to significant knowledge gaps regarding implications for pediatric care. This knowledge gap is attributed to historical ethical and legal ambiguities that hindered randomized controlled trials involving children, resulting in exclusion from research. Third, research targeting children is essential to understand these unique circumstances and deliver appropriate benefits. The U.S. Department of Health and Human Services and the Food and Drug Administration have emphasized the need to broaden pediatric research participation. A recent motion by the Hong Kong Legislative Council on "Promoting the Development of Children's Healthcare Services" further highlights this commitment. Finally, age-related factors may influence individuals' pain outcomes or responses. Children are more susceptible to the placebo effect than adults; this may be due to the stronger influence of parental (compared to professional) expectations on pediatric pain perceptions. Thus, caution is needed when generalizing adult findings to children. Investigating pain in children is crucial for developing tailored interventions for the pediatric population. This project will allow healthcare practitioners and physicians to learn about the possibility of tailoring, forming, or optimizing medical intervention strategies to enhance positive pain outcomes and novel pain management. For instance, practitioners, clinicians, and dentists could consider tailoring therapeutic interactions and treatments by incorporating appropriate procedures to reduce undesired negative pain outcomes.

Rule-Based High-Risk Flu

Previous work by the study team has shown that informing patients of their high risk of flu and flu-related complications increases their likelihood of getting a flu shot (Rosenbaum et al., 2026). In this work, an artificial intelligence (AI)-based algorithm determined which patients were at high risk for flu. This year, the team will test whether risk messages remain effective when a non-algorithmic rule-based additive risk index (McGovern et al., 2024) is used to identify patients at high risk.

Psychological and Lifestyle Factors on Health Outcomes

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design. A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.

Vaccine Knowledge, Attitudes and Practices Among Men Who Have Sex With Men: a Global Cross-sectional Study

This study aims to investigate vaccine-related knowledge, attitude, vaccine confidence and vaccine hesitancy among MSM across multiple countries and regions.

Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center

In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers. A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services. Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center. The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.

Microbe-Literacy Germ-Watching Workshops for Hygiene and Vaccine Acceptance in Sargodha, Pakistan

This cluster randomized controlled trial evaluated whether a single microscope-based "germ-watching" workshop, delivered by Lady Health Workers (LHWs) to mothers and female caregivers of children under three years, improves hygiene practices, vaccination attitudes and intentions, routine immunization, and trust in LHWs. Twelve Union Councils in Sargodha District, Pakistan, were allocated 1:1 to the intervention or routine services, with outcomes measured by structured baseline and endline surveys and facility immunization records.

"Facts Tell… and With Stories Sell?" Combining Viewer-tailored Personal Human Papillomavirus (HPV) Narrative Video With HPV Vaccine Information Video to Improve HPV Vaccine Uptake

This study will compare the use of informational videos only, personal story videos only, and the combination of both, to see which is most effective in increasing HPV vaccination.

Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months

Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services. The investigators will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the end line cross-sectional household survey, 2) in children aged 6-12 months at inclusion, in a longitudinal 12 months follow-up survey. Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the This study will be implemented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria. This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and end line cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized subsample of health facilities. Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm: * The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm; * The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.

ARISe at UMass Chan

The goal is to identify the most impactful strategies for capturing attention and enhancing effectiveness of vaccine promotion messages. This will be done using an online survey that employs remote eye-tracking and self report measures to evaluate response to sample vaccine promotion social media content in rural populations in New England. Participants will be randomly assigned into one of 14 conditions in a 2(source: expert vs. influencer) by 7 (themes: constructs from 7C Vaccine Framework) experiment and view sample messages and then answer questions about their attitudes and beliefs while being monitored for eye-tracking.

Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older

In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively. The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older. Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.

Can the Ergometric Test in Flu-like Syndrome Help in the Outcome Analysis of Unvaccinated Patients

During the flu-like syndrome, the cardiovascular risk is increased, especially in the elderly. Understanding whether blood pressure assessment during an exercise test can aid in the understanding of patient outcomes, thereby improving prognostic ability in clinical practice, is the focus of the present study. Therefore, the aim of this study is to evaluate the hemodynamic response of adults with flu-like symptoms, both vaccinated and unvaccinated, and to conduct a 30-day follow-up for assessment. Patients who are indicated for an ergometric test and present with flu-like syndrome will be selected. We will inquire about their vaccination history and perform the ergometric test to evaluate test duration, arrhythmias, and ischemias

OptiMAx Will Test Whether SQ-LNS Incentivises Vaccination Uptake in Rural Chad and Niger, With a Cost Effectiveness Analysis. It Will Also Look at Whether Having Received SQ-LNS Before Becoming Malnourished Leads to Better Outcomes for Children Treated Under the OptiMA Protocol.

Malnutrition and infectious disease form a vicious circle, posing a double threat to vulnerable children in low- and middle-income countries. Malnutrition makes children more vulnerable to infectious diseases, while infectious diseases increase the risk of malnutrition. When caught in this cycle, children are far more likely to die or suffer adverse effects on their health and development. High rates of wasting and low immunization coverage also constitute a weakening double burden for already fragile health systems. Every year in these contexts, hundreds of thousands of children are treated for severe wasting, while at the same time suffering repeated and prolonged epidemics of vaccine-preventable diseases such as measles. Rural areas of Chad and Niger are at the heart of this dynamic, recording some of the worst indicators of malnutrition and low vaccination coverage rates. Small-quantity lipid-based nutritional supplements (SQ-LNS) are a category of ready-to-use, nutrient-dense food supplements fortified with micronutrients, designed to prevent malnutrition and improve child survival, growth and development. A recent meta-analysis on SQ-LNS reveals that giving a child just one sachet of SQ-LNS a day for a year can reduce the risk of mortality by 27%, iron-deficiency anemia by 64%, severe wasting by 31% and severe stunting by 17%. The recent World Health Organization (WHO) guideline on complementary feeding of infants and young children aged 6 to 23 months recently recommended the use of SQ-LNS in certain contexts of food insecurity, based on evidence deemed "very safe". The distribution of SQ-LNS is also promising as an incentive for vaccination, as well as for other health services, such as participation in infant growth monitoring programs. Various operational experiences suggest that it is likely to have an impact on increasing vaccination coverage, and a modeling simulation suggests that it would lead to a significant reduction in measles morbidity and mortality. The main objective of OptiMAx is to estimate the effectiveness of a mass SQ-LNS supplementation program coupled with the routine immunization program compared with the routine immunization program alone in terms of vaccination coverage against pentavalent 1 (Niger) and measles 1 (Chad), after 12 months of program implementation, in children aged 12 to 23 months as part of an annual cross-sectional household survey. Secondary objectives include: * Estimate the effectiveness of a mass SQ-LNS supplementation program combined with the routine Essential Program on Immunization (EPI) compared with the routine EPI alone in children aged 6-18 months, after 12 months of program implementation, in terms of 1) coverage of pentavalent 3 vaccine, malaria and other childhood vaccines, 2) on-time immunization for age-eligible children. * Evaluate the feasibility and reliability of combining measles and pentavalent coverage measurements during annual MUAC-family training campaigns;. * Evaluate outcomes of acutely malnourished children who received SQ-LNS supplementation prior to RUTF treatment (as part of their inclusion in the OptiMA study) versus those who did not receive SQ-LNS supplementation The specific objectives of the process evaluation (with a sub-study on gender), modeling and economic evaluation are as follows: 1. Conduct a process evaluation of the OptiMAx intervention to understand how it works, for whom and where; 2. Understand to what extent and how gender-related facilitations and barriers affect the interaction and uptake of intervention, both on the demand side (health-seeking/intervention behaviors) and the supply side (provision of intervention services). 3. Estimate the health impact of the OptiMAx intervention, in terms of nutrition and vaccine-preventable diseases, using mathematical modeling approaches. 4. Quantify the relative costs associated with the OptiMAx intervention compared with the costs associated with existing vaccination activities in Mirriah, Niger, and Ngouri, Chad. 5. Estimate the cost-effectiveness of the OptiMAx intervention in Mirriah, Niger, and Ngouri, Chad.

Pediatric Vaccinations

As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

This Phase 3 double-blinded, randomized study aims to evaluate the safety and immunogenicity of the two-dose MVA-BN mpox vaccine regimen, administered subcutaneously, in infants and children aged 4 to 24 months in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection and complications. The study will compare the safety and immunogenicity of a full-dose regimen versus a half-dose regimen in this population. A hierarchical testing strategy will be applied as follows: first, non-inferiority of the full-dose regimen in infants/children (4-24 months old) will be evaluated against the full-dose regimen in adults from the POX-MVA-045 study. If non-inferiority is demonstrated, the immunogenicity of the half dose in infants/children (4-24 months old) will subsequently be tested for non-inferiority vs the full dose in adult. The trial will be conducted in Boende, Tshuapa Province, DRC. The trial plans to enroll 344 male and female infants/children, who will be randomized to receive two doses of the MVA-BN vaccine administered 28 days apart. Participants in Child Group 1 (N=172) will receive the standard vaccine dose (0.5 mL), while those in Child Group 2 (N=172) will receive half the standard dose (0.25 mL), with both groups following the same dosing schedule. This study builds on positive safety and immunogenicity data from prior trials that support the use of the standard dose regimen in younger children. However, considering the developmental differences in the immune systems of infants and young children/adolescents, it aims to evaluate whether a half-dose regimen can provide similar immunogenicity while potentially reducing reactogenicity. The findings will offer valuable insights into the optimal dosing strategy for this age group, balancing safety and immunogenicity to inform future vaccination recommendations.

Optimizing Weblinks Used in Digital Vaccination Invitations to Raise Trust and Booking Intention: Online Experiment 3

This study investigates how the design of weblinks in digital vaccination invitation emails influences recipient trust and their willingness to book an appointment. In this study, investigators compare three different link formats: a control third-party link previously used by the NHS, and two experimental weblinks: an improved version of the link, and a text embedded hyperlink. The study tests primarily whether the two experimental weblinks will be perceived as more trustworthy and increase booking intention than the control weblink. Furthermore, the study examined whether the experimental weblinks are perceived to be more fluent (easier to read) and improve participants' ability to correctly identify the organisation (e.g., the NHS or a US pharmacy) that sent the hypothetical email. To test these effects, investigators planned to gather data from 2,000 participants from the United Kingdom and 2,000 from the United States. They will be assigned to view one of the three hypothetical email versions. UK participants will see emails that appear to be from the NHS, while US participants see emails that appear to be from a local fictitious pharmacy. Due to US emails appearing to come from a fictitious pharmacy, investigators also expected that the benefit of correctly identifying the host organisation would be more pronounced in the United Kingdom than in the United States. This research aims to provide evidence on how to design more effective and trustworthy digital health communications.

Optimizing Weblinks Used in Digital Vaccination Invitations to Raise Trust and Booking Intention: Online Experiment 2

This study investigates how the design of web links in digital vaccination invitation emails affects recipient trust and their willingness to book an appointment. Researchers compare three different weblink formats: a control third-party link previously used by the NHS ("accurx"), and two experimental weblinks in which the original link is hidden: a shortened "bit.ly" link, and a text-embedded hyperlink. The study primarily tests whether the two experimental weblinks will be perceived as more trustworthy and increase booking intention compared to the control weblink. Furthermore, the study examines whether the experimental weblinks is perceived to be more fluent (easier to read) and improves participants' ability to correctly identify the organisation (e.g., the NHS or a US pharmacy) that sent the hypothetical email. To test these effects, investigators will gather data from 600 participants from the United Kingdom and 600 from the United States. They will be randomly assigned to view one of the three hypothetical email versions. UK participants will see emails appearing to be from the NHS, while US participants will see emails from a fictitious pharmacy (Pharma-US). This research aims to provide evidence on how to design more effective and trustworthy digital health communications.

Optimizing Weblinks Used in Digital Vaccination Invitations to Raise Trust and Booking Intention: Online Experiment 1

This study investigates whether the design of weblinks in digital vaccination invitations affects how much people trust the message and their willingness to book an appointment. Researchers compare a standard third-party weblink used by the NHS ("accurx.thirdparty.nhs.uk/r/aafwaczmd5") with an improved, more transparent weblink (https://vaccine-booking.nhs.uk). The study tests the hypothesis that the improved link will be perceived as more trustworthy and easier to read than the standard link. Further, the study tests whether participants would be more likely to correctly identify the sender and would be more willing to book a vaccine when shown the improved link. To test these effects, the investigators planned to conduct a study with 600 participants from the United Kingdom and 600 from the United States. Participants will be randomly assigned to view one of the two hypothetical email versions. UK participants will see an email that appears to be from the NHS. US participants will see an email from a fictitious pharmacy (Pharma-US).This research aims to provide evidence on how to design more trustworthy digital health communications when recipients are asked to click a weblink.

Can Stories Encourage the Elderly to Vaccinate? Combining Viewer-tailored Personal Narrative Videos With Informational Videos to Improve Vaccine Uptake Among Older Adults

This study will compare the use of informational videos only, personal story videos only, and the combination of both, to see which is most effective in increasing vaccination among older adults.

Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC

This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection. The study will be conducted in Boende, Tshuapa Province, DRC. A total of 359 maternal participants, aged 16 to 35 and in their second or third trimester of pregnancy, will be enrolled. Participants will be randomly assigned to receive two subcutaneous doses of the MVA-BN vaccine, given 28 days apart, either during pregnancy (Maternal Group 1) or within 72 hours after delivery (Maternal Group 2). Additionally, pregnant women in any trimester who have been recently exposed to a confirmed mpox case will be enrolled in the post-exposure prophylaxis (PEP) arm (Maternal Group 3), receiving the vaccine as soon as possible after exposure-ideally within four days but up to 14 days if they remain asymptomatic. The study will evaluate the safety, reactogenicity, and immune responses of vaccinated pregnant women compared to healthy adults in the POX-MVA-045 study (NCT06549530) through non-inferiority analyses. Participants will be monitored for immunogenicity and safety for 13 months post-delivery, while neonates will be observed for safety over the same period. The trial will also compare outcomes between women vaccinated during pregnancy and those vaccinated postpartum, assess the transfer of maternal immunity to neonates, and explore correlations between maternal antibody levels in serum and breast milk. This study seeks to provide strong evidence supporting the safety and immunogenicity of the MVA-BN mpox vaccine in pregnancy, contributing to global public health efforts to protect at-risk women and their infants in mpox-endemic regions.