- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933685
Study of Immune Responses Induced by a HIV Vaccine
September 18, 2019 updated by: U.S. Army Medical Research and Development Command
Randomized, Double Blind Evaluation of Sequential Administration of gp120 B/E (AIDSVAX B/E) (GSID) With 1-Year Boosting in HIV-uninfected Thai Adults
The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX B/E.
Blood and mucosal samples will be collected to assess immune responses.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to define in HIV-uninfected volunteers the innate, cell-mediated and humoral responses induced by AIDSVAX B/E in the systemic and mucosal compartments and to characterize B cell functional specificities in peripheral blood, bone marrow and sigmoid compartments.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Thai Red Cross Aids Research Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female volunteers between age 20 and 40, available for follow up in Bangkok for a period of 18 months and having a Thai identification card.
- Must be at low risk for HIV infection per investigator assessment.
- Can read and write Thai language and must be able to understand and complete the informed consent process.
- Must successfully complete a Test of Understanding (TOU) prior to enrollment.
- Must be in good general health without clinically significant medical history.
- HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
Laboratory screening analysis (within normal institutional range):
- Hemoglobin: Women >/= 12.0 g/dL, Men >/= 12.5 g/dL
- White cell count: 4,000 to 11,000 cells/mm^3
- Platelets: 150,000 to 450,000/mm^3
- ALT and AST </= 1.25 institutional upper limit of reference range
- Creatinine: </= 1.25 institutional upper limit of reference range
- Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
Female-Specific Criteria:
- Negative human choriogonadotropin (β-HCG) urine pregnancy test for women at screening and prior to each vaccination (same day), and prior to invasive procedures.
- Use of adequate birth control methods followed for 45 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3 months after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence.
Exclusion Criteria:
- Active, untreated syphilis
- Asplenia: any condition resulting in the absence of a functional spleen
- Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international normalized ration (INR) of partial prothrombin time (PTT)
- Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the window between study enrollment and 3 months after the last vaccination visit.
- Male or female who has exchanged money or goods for sex in the last 12 months.
- An intravenous drug user in the last 12 months.
- History of anaphylaxis or other serious adverse reaction to vaccines any time in the past, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including streptomycin or neomycin.
Subject has received any of the following substances:
- Chronic use of therapies that may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of >/= 20 mg/day prednisone equivalent for periods exceeding 10 days). The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulins within 30 days prior to HIV screening.
- Any licensed vaccine within 14 days prior to initial study vaccine administration in the present study.
- Receipt of any investigational HIV vaccine.
- Investigational research agents or vaccine within 30 days prior to initial study vaccine administration in the present study.
- Use of anti-tuberculosis prophylaxis or therapy during the past 90 days.
- Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol compliance or impairs a subjects ability to give informed consent.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide ideation or attempt.
- Study site employees who are involved in the protocol and/or may have direct access to study related area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AIDSVAX B/E
AIDSVAX B/E at Weeks 0, 4, 24 and 48
|
1 mL per injection (300 ug dose/antigen for a total of 600 ug/dose administered)
|
Placebo Comparator: AIDSVAX B/E Placebo
AIDSVAX B/E Placebo at Weeks 0, 4, 24 and 48
|
1 mL per injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Immune Response
Time Frame: Through Week 72
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Characterization of vaccine-induced immune responses in the systemic and mucosal compartments by intracellular cytokine staining (ICS) and IFN-gamma ELISPOT at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
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Through Week 72
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Change in Humoral Response
Time Frame: Through Week 72
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Characterization of vaccine-induced humoral immune response in the systemic and mucosal compartments by binding and neutralizing antibodies at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
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Through Week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Monitoring
Time Frame: Through Week 49
|
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling and limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards during the 3 days post-vaccination.
|
Through Week 49
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nittaya Phanuphak,, MD, PhD, Thai Red Cross Aids Research Centre
- Study Chair: Jintanat Ananworanich, MD, PhD, US Military HIV Research Program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2014
Primary Completion (Actual)
May 24, 2016
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
August 28, 2013
First Posted (Estimate)
September 2, 2013
Study Record Updates
Last Update Posted (Actual)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RV 328
- 1939 (Other Identifier: WRAIR IRB)
- S-11-0005 (Other Identifier: Sponsor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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