Clinical Research Directory

R21/MM Dosing, Presentations, and Preservatives

This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. All participants will receive the same number of injections and will be randomly assigned to receive one of the followings: * Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125). * Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125) * Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125) Clinical procedure for participants: * Standardized symptom questionnaire * Physical examination: Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential) * Venous blood collection (Pre-vaccination) 3mL * Vaccination

Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood. This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.

Intradermal Influenza Vaccination

The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time.

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant

Streptococcus pneumoniae is a common bacteria and major cause of serious infections like bloodstream infections, pneumonia, and meningitis. These infections are most common in children under 2 years old and adults over 65 years of age and dangerous for all age groups. Current vaccines, which contain parts of the bacteria, have significantly reduced the incidence of invasive pneumococcal disease (IPD). To broaden protection more serotypes are added to the vaccines over the years, which results in lower immune responses to the serotype-specific polysaccharides while a stronger vaccine is desired for older people and people with a weakened immune system. In addition, these complex vaccines are hardly affordable for the growing group of older adults in low- and middle-income countries (LMICs). To address these challenges, a new potent adjuvant called 'LiteVax Adjuvant' was developed. It has been shown to improve the efficacy of vaccines, even at low doses of antigen. A lower antigen dose reduces the costs of vaccines and promotes accessibility in LMICs. By testing a standard and a low dose of a commercial pneumococcal conjugate vaccine combined with LiteVax Adjuvant in healthy volunteers, we aim to determine whether the adjuvant enhances the immune response and if a lower vaccine dose is effective. At the same time, the safety of the vaccines is being investigated.

Optimal Timing of Hepatitis B Vaccination After Transplants

The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.

Long COVID and Its Associations With Health Outcomes in Older Adults

The Peking University Health Cohort in Anning, Yunnan (PKUHC-AN) is a prospective cohort study carried out in Anning, Yunnan. The primary aim of this study is to investigate the impact of COVID-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of COVID-19 and other emerging infectious diseases. Data will be collected regarding health status, history of COVID-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants

This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: * gut microbiome composition and diversity at 4 weeks of life * markers of intestinal inflammation and microbial translocation at 4 weeks of life * Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: * longitudinal succession of the gut microbiota composition, diversity and function * relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life * stool metabolome * T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: * infant growth * all-cause morbidity * neurodevelopment during the first 9 months of life * antibody responses to early childhood vaccines

Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza

The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant).