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New treatment option for HIV
Official title A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.
ClinicalTrials.gov ID: NCT06617091
What this study is testing
What is GRAdHIVNE1 Vaccine?
GRAdHIVNE1 Vaccine is an investigational medicine, being studied as a potential treatment for hiv.
Also referred to as gorilla-isolated adenovirus (GRAd32) vector.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the...
- All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to...
- Intrauterine device, or contraceptive implant
You likely can't join if
- Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the...
- For the PLWH (Part B), history of AIDS-defining illness or CD4 \< 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance...
See the full eligibility criteria
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to...
- All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to receiving the IP until 4 months following the last IP administration...
- Intrauterine device, or contraceptive implant
- Hormonal contraception
- Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy (\< 1 year ago), or [2] a vasectomy more than 2 years ago with no...
- Women who have undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, as well as those who are postmenopausal (\> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at...
- Willing to forgo donations of blood, or any other tissues during the study. Additional for PLWH
- Confirmed HIV infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing on screening visit.
- CD4 ≥ 500 cells/µl at screening.
- Currently on ART, and documentation of continuous combination ART (cART) for at least 12 months with suppression of plasma HIV-1 viral load \< 50 copies / ml for greater than 6 months prior to trial entry, measured on...
- Viral load \< 50 copies / ml at time of screening (within 28 days prior to IP administration).
- Must commit to adhering to a suppressive ART regimen for the duration of the study
- Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the opinion of the investigator makes the participant unsuitable for...
- For the PLWH (Part B), history of AIDS-defining illness or CD4 \< 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance. Bleeding disorder that was diagnosed by a physician (e.g., Factor...
The study team makes the final eligibility decision.
Where it's taking place
- Mtubatuba, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
- Harare, Harare, Zimbabwe
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mtubatuba, KwaZulu-Natal, South Africa; Cape Town, Western Cape, South Africa; Harare, Harare, Zimbabwe. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.