CompletedPhase 1/2

Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults

United States, South Africa334 participantsStarted 2016-12-07

Plain-language summary

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

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: General and Demographic Criteria * Age of 18 to 40 years * Access to a participating HVTN clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit * Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count grea…

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 Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Timeframe: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Timeframe: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Timeframe: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

Number of Participants Reporting Serious Adverse Events (SAEs)

Timeframe: Measured through Month 12

Trial details

NCT IDNCT02915016

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-08-07

Results submitted2020-08-10

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