CompletedPhase 1

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Kenya143 participantsStarted 2021-03-15

Plain-language summary

This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS). The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy, male and female participant aged 18 to 40 years and available for 26 months. * Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool. * Must be able to understand and complete the informed consent process. * Must be capable of reading English or Kiswahili. * Must agree to a home visit. * Must complete a Test of Understanding (TOU) before enrollment. Must answer 9 out of 10 questions correctly with a maximum of three attempts. * Must be in good general health without a clinically significant medical history. * HIV-uninfected per diagnostic algorithm within 45 days of enrollment. * Laboratory values: * Hemoglobin * 12.5-18.1 g/dL men * 11.0-16.1 g/dL women * White Cell Count * 2.7-7.7 x 10³ cells/µL men * 3.0-9.1 x 10³ cells/µL women * Platelets: * 125-370 10³ cells/µL men * 125-444 10³ cells/µL women * ALT and AST: ≤1.25 institutional upper limit of the reference range * Creatinine: ≤1.25 institutional upper limit of the reference range * Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose Female-Specific Criteria * Negative urine pregnancy test for women at screening, the day of each vaccination, and before any invasive procedure. * Already using and commits to continued use of an adequate birth control method for 45 days before to the first vaccination/placebo vaccination, and for at least 90 days after the final vaccine/plac…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)

Timeframe: Day 1-Day 7 Post Vaccination 1

Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)

Timeframe: Day 1-Day 7 Post Vaccination 2

Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)

Timeframe: Day 1-Day 7 Post Vaccination 3

Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)

Timeframe: Day 1-Day 7 Post Vaccination 4

Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)

Timeframe: Day 1-Day 7 Post Vaccination 5

Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)

Timeframe: Day 1-Day 7 Post Vaccination 6

Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)

Trial details

NCT IDNCT04826094

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-02-13

Results submitted2025-02-14

View on ClinicalTrials.gov More HIV Infections trials