RecruitingHIV
A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.
Eligible age
18–50 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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
Sponsor: International AIDS Vaccine Initiative
You may qualify if…
- ✓ 1. 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.
- ✓ 2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- ✓ 3. 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 administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
- ✓ 4. 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, including:
- ✓ 1. Intrauterine device, or contraceptive implant
- ✓ 2. Hormonal contraception
- ✓ 3. 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 resultant pregnancy despite sexual activity post-vasectomy)
- ✓ 5. 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 least 6 months and a serum follicle stimulating hormone \[FSH\] level \> 40 IU/L) will not be required to use contraceptives.
You may not qualify if…
- ✕ 1. 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 participation in the study.
- ✕ 2. For the PLWH (Part B), history of AIDS-defining illness or CD4 \< 200 cells/µl.
- ✕ 3. If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- ✕ 4. 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 deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
- ✕ 6\. History of a splenectomy. 7. Previous receipt of an adenovirus vectored vaccine. 8. Receipt of live attenuated vaccine or other vaccine within the previous 60 days or planned receipt within 180 days after administration of IP. Receipt of blood transfusion or blood derived products within the previous 3 months.
- ✕ 9\. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.
- ✕ 10\. Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval).
Source: ClinicalTrials.gov · NCT06617091 · last updated 2026-02-13