A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa
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
• 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 administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
• 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:
∙ 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 resultant pregnancy despite sexual activity post-vasectomy)
• 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.
• Willing to forgo donations of blood, or any other tissues during the study.
• Additional Inclusion criteria 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 at least 2 independent occasions that can include the screening viral load. cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non-nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.
⁃ 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