Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
NCT ID: NCT02915016
Last Updated: 2022-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
334 participants
INTERVENTIONAL
2016-12-07
2020-02-12
Brief Summary
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Detailed Description
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The study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned to one of eight groups, and each group will receive a different sequence of vaccines during the study. Groups 1 and 4 will receive the DNA-HIV-PT123 vaccine, the Protein/MF59 vaccine, and placebo. Groups 2, 3, 5, 6, and 7 will receive the DNA-HIV-PT123 vaccine, the Protein/AS01B vaccine, and placebo. Group 8 will only receive placebo.
All participants will receive their assigned vaccines at Months 0, 1, 3, and 6. Each of these visits will include three injections. Follow-up visits will occur at Week 2 and Months 1.5, 3.5, 6.25, 6.5, 9, and 12.
Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk reduction counseling, and urine and blood collection. Participants may optionally choose to provide stool, rectal fluid, cervical fluid, or semen samples. Participants will be contacted 6 months after the last scheduled visit by phone, text message, or e-mail for information about their health.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 7: Placebo + Protein/AS01B
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Group 8: Placebo
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Interventions
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DNA-HIV-PT123 vaccine
Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Bivalent Subtype C gp120/AS01B vaccine
Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo
Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age of 18 to 40 years
* Access to a participating HVTN clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
* Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
* Willingness to receive HIV test results
* Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
* Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC)
* Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
* White blood cell count equal to 3,300 to 12,000 cells/mm\^3
* Total lymphocyte count greater than or equal to 800 cells/mm\^3
* Remaining differential either within institutional normal range or with site physician approval
* Platelets equal to 125,000 to 550,000/mm\^3
Chemistry
* Chemistry panel: ALT, AST, and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.
Virology
* Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations.
* Negative Hepatitis B surface antigen (HBsAg)
* Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
* Normal urine:
* Negative urine glucose, and
* Negative or trace urine protein, and
* Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).
Reproductive Status
* Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status:
United States
A volunteer who was born female must:
* Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in the United States is defined as using any 1 or more of the following methods:
* Condoms (male or female) with or without a spermicide,
* Diaphragm or cervical cap with spermicide,
* Intrauterine device (IUD),
* Hormonal contraception, or
* Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or
* Any other contraceptive method approved by the HVTN 108 protocol safety review team (PSRT)
* Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
* Or be sexually abstinent.
Southern Africa
A volunteer who was born female must:
* Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in Southern Africa is defined as using 2 methods of birth control. These include 1 of the following methods:
* Condoms (male or female)
* Diaphragm or cervical cap
* PLUS 1 of the following methods:
* IUD,
* Hormonal contraception (in accordance with applicable national contraception guidelines), or
* Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or
* Any other contraceptive method approved by the HVTN 108 PSRT
* Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
* Or be sexually abstinent.
* Volunteers who were born female 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
Other
Volunteers 21 years of age and older who were born female consenting to provide cervical samples:
* Pap smear within:
* the 3 years prior to enrollment with the latest result reported as normal or atypical squamous cells of undetermined significance (ASCUS), or
* the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk human papillomavirus (HPV).
* If no pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection.
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; or BMI greater than or equal to 35 with 2 or more of the following: systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
* 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 108 study
* Pregnant or breastfeeding
* Active duty and reserve US military personnel
Vaccines and Other Injections
* HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 108 PSRT will determine eligibility on a case-by-case basis.
* Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 108 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 108 PSRT on a case-by-case basis.
* Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
* Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
* Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System
* Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
* Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
* Immunoglobulin received within 60 days before first vaccination
* Autoimmune disease
* Immunodeficiency
Clinically significant medical conditions
* Untreated or incompletely treated syphilis infection
* 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:
* A process that would affect the immune response,
* A process that would require medication that affects the immune response,
* Any contraindication to repeated injections or blood draws,
* A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
* A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
* 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, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent US 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 moderate/high dose inhaled corticosteroids, or
* In the past year has either of the following:
* Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
* Needed emergency care, urgent care, hospitalization, or intubation for asthma.
* Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
* Thyroidectomy, or thyroid disease requiring medication during the last 12 months
* Hypertension:
* If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
* If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
* Bleeding disorder diagnosed by a doctor (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 3 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 hereditary angioedema, acquired angioedema, or idiopathic angioedema.
18 Years
40 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Nigel Garrett
Role: STUDY_CHAIR
Centre for the AIDS Programme of Research in South Africa
Locations
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Alabama CRS
Birmingham, Alabama, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health (FH) CRS
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Kliptown Soweto CRS
Johannesburg, Gauteng, South Africa
The Aurum Institute Tembisa Clinical Research Centre CRS
Johannesburg, Gauteng, South Africa
Soweto HVTN CRS
Johannesburg, Gauteng, South Africa
Setshaba Research Centre CRS
Soshanguve, Gauteng, South Africa
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, KwaZulu-Natal, South Africa
Verulam CRS
Verulam, KwaZulu-Natal, South Africa
Aurum Institute Klerksdorp CRS
Klerksdorp, North West, South Africa
Emavundleni CRS
Cape Town, Western Cape, South Africa
Countries
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References
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Conley HE, Oh SY, Garrett N, Kublin J, Monaco CL, Watts S, Jha S, Ferrari G, Tomaras GD, Geraghty DE, Chan C, Pollara J. IgG and Fc Receptor Genetic Variation Associates With Functional Antibody Responses in a DNA and Protein Candidate HIV Vaccine Trial. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):371-375. doi: 10.1097/QAI.0000000000003734.
Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7.
Garrett N, Dintwe O, Monaco CL, Jones M, Seaton KE, Church EC, Grunenberg N, Hutter J, deCamp A, Huang Y, Lu H, Mann P, Robinson ST, Heptinstall J, Jensen RL, Pantaleo G, Ding S, Koutsoukos M, Hosseinipour MC, Van Der Meeren O, Gilbert PB, Ferrari G, Andersen-Nissen E, McElrath MJ, Tomaras GD, Gray GE, Corey L, Kublin JG; HVTN 108 and HVTN 111 Study Teams. Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial. J Acquir Immune Defic Syndr. 2024 Aug 1;96(4):350-360. doi: 10.1097/QAI.0000000000003438. Epub 2024 Jun 21.
Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, Gaffoor Z, Goga A, Andrasik M. Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa. Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7.
Mngadi KT, Maharaj B, Duki Y, Grove D, Andriesen J. Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 3;7(10):e175. doi: 10.2196/resprot.9396.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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12007
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 108
Identifier Type: -
Identifier Source: org_study_id
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