Status and phase
Conditions
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Study type
Funder types
Identifiers
About
The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.
Full description
This study will evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.
Participants will be randomly assigned to one of five groups. Participants in all five groups will receive GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Then, at Months 4, 6, and 10, participants will receive three additional injections according to their assigned group:
Participants will attend several study visits through Month 16. Visits may include physical examinations, blood and urine collection, electrocardiogram, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 24 for follow-up health monitoring.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
General and Demographic Criteria
HIV-Related Criteria:
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
Chemistry
HIV Status
Urine
Normal urine:
Reproductive Status
Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was assigned female sex at birth:
Must agree to consistently use effective contraception (see the study protocol) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 3 months after the final study vaccination. Effective contraception is defined as using the following methods:
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, or bilateral oophorectomy;
Or be sexually abstinent.
Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit.
Exclusion Criteria
Blood products received within 120 days before first vaccination.
Investigational research agents received within 30 days before first vaccination.
Body mass index (BMI) greater than or equal to 40.
Volunteer has 2 or more of the following cardiac risk factors:
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 132 study.
Pregnant or breastfeeding.
Active duty and reserve US military personnel.
Vaccines and other Injections
Immune System
Cardiac
Clinically significant medical conditions
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.
Psychiatric condition that 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.
Current anti-tuberculosis (TB) prophylaxis or therapy.
Asthma other than mild or moderate, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report.) Exclude a volunteer who:
Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
Uses high dose inhaled corticosteroids, or
In the past year has had either of the following:
Diabetes mellitus type 1 or type 2 (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months. (Not exclusionary: well-controlled non-autoimmune thyroid disease.)
Hypertension:
Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions.)
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study.)
Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen.
History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.)
Primary purpose
Allocation
Interventional model
Masking
0 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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