# Clinical Core: Core B

> **NIH NIH U19** · DREXEL UNIVERSITY · 2021 · $24,118

## Abstract

CLINICAL CORE B abstract 
The goal of the Clinical Core is to provide a central rich store of data and specimens from two 
independently funded ‘Simulated HIV Vaccine Efficacy Trial’ using Hepatitis B vaccine in 
Uganda to support the translational activities for the U19 program. Leadership of the Core will 
be provided by Dr. Noah Kiwanuka, who is Executive Director of the UVRI-IAVI HIV Vaccine 
Program. Dr. Kiwanuka will be assisted by Pontiano Kaleebu, the Director of the MRC/UVRI 
Uganda Research Unit and Deputy Director Uganda Virus Research Institute (UVRI), Entebbe, 
and by Dr. Bernard Bagaya. The leaders have long experience in conduct of clinical trials, 
laboratory analysis and international collaborations, and the UVRI laboratories are fully 
equipped. The International AIDS Vaccine Initiative, sponsor of the trials, will provide scientific 
expertise, and support, technical and quality assurance. The trials have been carried out with 
appropriate ethical approvals and informed consent, by investigators skilled in clinical work, 
according to Good Clinical Practices. Communities are informed and supportive of the trials, 
both because of the ancillary benefits of medical research to their populations and because they 
appreciate the importance of the work. The Clinical Core will manage the epidemiologic data 
and laboratory data generated in Uganda, in a clinical database, and share coded data with 
Consortium partners. Specimens from these two trials will be tracked and managed using a 
LIMS system and shipped to the IAVI Human Immunology Laboratory (HIL), Imperial College 
London, which will securely store specimens. The Clinical Core will assess Hepatitis B titers, 
subclinical malaria by whole blood PCR and the types and infestation level of intestinal 
helminths by PCR and microscopy. (Young investigators (Bagaya, Kyosimiire-Lugemwa) from 
Uganda have been included in the Projects, and will carry out some immunologic assays in that 
capacity.) Shipments of samples will be managed by IAVI HIL, which ships many thousands of 
specimens to and from Africa and other destinations each year. Data management will be 
carried out according to highest quality and confidentiality standards. Laboratories are skilled 
and certified for Good Clinical Laboratory Practices, and shipment processes are per IATA 
regulations. The Clinical Research Core will interact closely with investigators involved in 
Research Projects and the Cores to accomplish the following specific aims.

## Key facts

- **NIH application ID:** 10224803
- **Project number:** 5U19AI128910-05
- **Recipient organization:** DREXEL UNIVERSITY
- **Principal Investigator:** PONTIANO KALEEBU
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $24,118
- **Award type:** 5
- **Project period:** 2017-08-10 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10224803

## Citation

> US National Institutes of Health, RePORTER application 10224803, Clinical Core: Core B (5U19AI128910-05). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10224803. Licensed CC0.

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