A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in healthy, HIV-uninfected adults
- Conditions
- AIDSHIV10047438
- Registration Number
- NL-OMON54857
- Lead Sponsor
- International AIDS Vaccine Initiative (IAVI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
1. Healthy adults as assessed by a medical history, physical exam, and
laboratory tests;
2. At least 18 years of age on the day of screening and has not reached his/her
51 birthday on the day of first IP administration;
3. Willing to comply with the requirements of the protocol and be available for
follow-up for the planned duration of the study;
4. 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 IP
administration and participation in the trial; written informed consent will be
obtained from the volunteer before any study-related procedures are performed;
5. Willing to undergo HIV testing, risk reduction counselling and receive HIV
test results;
6. All volunteers born female who are engaging in sexual activity that could
lead to pregnancy must commit to use an effective method of contraception at
the time of the first IP administration and for 4 months following the last IP
administration;
7. All volunteers born female who are not heterosexually active at screening
must agree to utilize an effective method of contraception if they become
heterosexually active as outlined above;
8. All volunteers born female must be willing to undergo urine pregnancy tests
at time points indicated in the Study Protocol;
9. All sexually active volunteers born male, regardless of reproductive
potential, must be willing to use an effective method of contraception (such as
consistent condom use) from the day of the first IP administration until at
least 4 months after the last IP administration;
10. Willing to forgo donations of blood, or any other tissues during the study
and, for those who test HIV-positive due to IP-induced antibodies, until the
anti-HIV antibody titers become undetectable.
1. Confirmed HIV-1 or HIV-2 infection;
2. Any clinically relevant abnormality on history or examination, including
history of immunodeficiency or autoimmune disease; use of systemic
corticosteroids (the use of topical or inhaled steroids is permitted),
immunosuppressive, anticancer, antituberculosis or other medications considered
significant by the investigator within the previous 6 months. Specified
exceptions apply (refer to the Study Protocol);
3. Any clinically significant acute or chronic medical condition that is
considered progressive or in the opinion of the investigator makes the
volunteer unsuitable for participation in the study;
4. Reported behavior which put the volunteer at risk for HIV infection within 6
months prior to IP administration. Refer to the Study protocol for further
details;
5. If female, pregnant or planning a pregnancy during the period of enrolment
until 4 months after the last IP administration; or lactating;
6. Bleeding disorder that was diagnosed by a physician (e.g., factor
deficiency, coagulopathy or platelet disorder that requires special
precautions). Note: A volunteer who states that he or she has easy bruising or
bleeding, but does not have a formal diagnosis and has IM injections and blood
draws without any adverse experience is eligible;
7. Infectious disease diagnosis: chronic hepatitis B infection
(HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA
positive or interferon-alfa treatment for hepatitis C infection in the past
year or interferon-alfa-free treatment for hepatitis C infection completed in
the past 6 months), or active syphilis (screening and confirmatory tests);
8. History of splenectomy;
9. Any of the abnormal laboratory parameters listed in the Study Protocol;
10. Receipt of live attenuated vaccine within the previous 30 days or planned
receipt within 30 days after IP administration; or receipt of other vaccine
within the previous 14 days or planned receipt within 14 days after IP
administration. (Exception is live attenuated influenza vaccine within 14
days.);
11. Receipt of blood transfusion or blood-derived products within the previous
3 months;
12. Participation in another clinical trial of an investigational product
currently, within the previous 3 months or expected participation during this
study; concurrent participation in an observational trial not requiring blood
or tissue sample collection is not an exclusion;
13. Prior receipt of any investigational HIV vaccine candidate or HIV
monoclonal antibody
Note: receipt of placebo in a previous HIV vaccine trial or monoclonal antibody
trial will not exclude a volunteer from participation if documentation is
available and the Medical Monitor gives approval;
14. History of significant local or systemic reactogenicity to vaccines (e.g.,
anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or
ulceration);
15. Psychiatric condition that compromises safety of the volunteer and
precludes compliance with the protocol. Specifically excluded are persons with
psychoses within the past 3 years, ongoing risk for suicide, or history of
suicide attempt or gesture within the past 3 years;
16. Seizure disorder: A volunteer who has had a seizure in the last 3 years is
excluded. (Not excluded: a volunteer wit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Proportion of volunteers with >= grade 2 adverse events (AEs) from day 0<br /><br>through day 7 after each vaccine administration<br /><br>2. Proportion of volunteers with vaccine-related adverse events (AEs),<br /><br>including safety laboratory (biochemical, haematological) parameters, from the<br /><br>day of each vaccine administration up to 28 days post each vaccine<br /><br>administration<br /><br>3. Proportion of volunteers with grade 2 or greater adverse events (AEs),<br /><br>including safety laboratory (biochemical, haematological) parameters, from the<br /><br>day of each vaccine administration up to 28 days post each vaccine<br /><br>administration<br /><br>4. Proportion of volunteers with vaccine-related serious adverse events (SAEs)<br /><br>throughout the study period<br /><br>5. Proportion of volunteers in each group with potential immune-mediated<br /><br>diseases (pIMDs) from the day of first vaccine administration throughout the<br /><br>study period </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Frequency and magnitude of binding antibody responses to BG505 SOSIP.GT1.1<br /><br>gp140 after the first, second, and/or third vaccine administrations compared to<br /><br>baseline.</p><br>