A study to test three experimental HIV vaccines in healthy adults
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202006495409011
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 88
•Healthy male and female as assessed by a medical history, physical exam, and laboratory tests.
•At low risk of HIV infection and willing to maintain low-risk behaviour for the duration of the trial. Individuals from key populations are not excluded provided they are assessed to be at low risk of HIV infection at screening and are willing to maintain low-risk behaviour during the study.
•At least 18 years of age on the day of screening and have not reached their 51st birthday on the day of the first vaccination.
•Willing and able to give informed consent for participation in the trial before any study-related procedures are performed. Volunteers will pass an Assessment of Understanding before signing the consent form.
•Willing to comply with the requirements of the protocol and be available for follow up for the planned duration of the study.
•Willing to undergo HIV testing, risk reduction counselling, receive HIV test results
•All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier method of birth control) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until 4 months after the last vaccination.
• If a female of childbearing potential, willing to use an effective non-barrier method of contraception (hormonal contraceptive or intrauterine device) from at least 2 weeks prior to first vaccination until at least 4 months after the last study vaccination. If not of childbearing potential: 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) or surgically sterile: no additional contraception required.
•All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to each s
Confirmed HIV-1 or HIV-2 infection
•Receipt of any vaccine in the previous 28 days or planned receipt within 28 days of Investigational Medicinal Product.
•Participation in another clinical trial of an Investigational Medicinal Product currently, within the previous 3 months or expected participation during the study.
•Receipt of another investigational HIV vaccine candidate or investigational adenoviral vectored vaccine (Note: receipt of an HIV vaccine placebo will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval).
•Receipt of blood transfusion or blood-derived products within the previous 4 months or expectation of receiving blood products during the study period.
•Receipt of immunoglobulin products within the previous 3 months.
•If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last study vaccination; or lactating.
•Any clinically relevant abnormality on history or examination such as:
•Any confirmed or suspected history of immunodeficiency including recurrent severe infections;
•Use of systemic corticosteroids for >14 days (use of topical or inhaled steroids is permitted) within the previous 6 months;
•Immunosuppressive, anti-cancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months.
•History of splenectomy.
•History of autoimmune disease
• History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, or clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow up).
•History of cancer (except basal cell carcinoma of the skin)
•Asthma that is not well controlled.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
•History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of volunteers who experience local and systemic reactogenicity events<br>2. Proportion of vaccine recipients developing HIV-1 specific T-cell responses <br>3. Proportion of volunteers with vaccine related serious adverse events (SAEs)<br>4. Proportion of vaccine recipients developing HIV-1 specific T-cell responses <br>
- Secondary Outcome Measures
Name Time Method 1. Frequency, breadth and duration of T-cell responses to conserved epitopes measured in the IFN-? ELISPOT assay in each vaccine recipient<br>2. Breadth of inhibition of HIV-1 viruses representative of circulating viruses in Kenya, Uganda and Zambia and other global clades in the in vitro Virus Inhibition Assay<br>