AzTrials
AzTrials

HIV InfectionsPhase 1/2NCT02915016

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

A Phase 1/2 study testing DNA-HIV-PT123 vaccine, Bivalent Subtype C gp120/MF59 vaccine and Bivalent Subtype C gp120/AS01B vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
DNA-HIV-PT123 vaccine, Bivalent Subtype C gp120/MF59 vaccine and Bivalent Subtype C gp120/AS01B vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
17 sitesin 2 countries
Study dates
7 Dec 2016to 12 Feb 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General and Demographic 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
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  • 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.

Who cannot join

  • General
  • 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
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  • 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 condition specifically listed among the exclusion criteria below.
  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

South Africa9 sites

  • Emavundleni CRS

    Cape Town, Western Cape, 7750

  • CAPRISA eThekwini CRS

    Durban, KwaZulu-Natal, 4013

  • Kliptown Soweto CRS

    Johannesburg, Gauteng, 1409

  • The Aurum Institute Tembisa Clinical Research Centre CRS

    Johannesburg, Gauteng, 1632

  • Soweto HVTN CRS

    Johannesburg, Gauteng, 1862

  • Aurum Institute Klerksdorp CRS

    Klerksdorp, North West, 2571

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith, KwaZulu-Natal, 3370

  • Setshaba Research Centre CRS

    Soshanguve, Gauteng, 0152

  • Verulam CRS

    Verulam, KwaZulu-Natal, 4340

Other trials in South Africa

United States8 sites

  • Alabama CRS

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

    Boston, Massachusetts, 02115-6110

  • Fenway Health (FH) CRS

    Boston, Massachusetts, 02215-4302

  • Vanderbilt Vaccine (VV) CRS

    Nashville, Tennessee, 37232-2582

  • Columbia P&S CRS

    New York, New York, 10032-3732

  • New York Blood Center CRS

    New York, New York, 10065

  • University of Rochester Vaccines to Prevent HIV Infection CRS

    Rochester, New York, 14642

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DNA, and of MF59®- or AS01B-Adjuvanted Clade C Env Protein in Various Combinations, in Healthy, HIV-Uninfected Adult Participants

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerability, and immune response of the DNA-HIV-PT123 vaccine when used in combination with one of two protein vaccines: Bivalent Subtype C gp120/MF59 (Protein/MF59) or Bivalent Subtype C gp120/AS01B (Protein/AS01B). These protein vaccines may boost the immune response to the DNA vaccine.

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
HIV Infections
Being tested
DNA-HIV-PT123 vaccine, Bivalent Subtype C gp120/MF59 vaccine, Bivalent Subtype C gp120/AS01B vaccine, Placebo
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA-HIV-PT123 vaccineBiological

    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 vaccineBiological

    Also called Protein/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 vaccineBiological

    Also called Protein/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.

  • PlaceboBiological

    Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.

Study groups in NCT02915016
Study groupRoleWhat they receive
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59ExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/MF59 vaccine; Biological: Placebo
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/AS01B vaccine; Biological: Placebo
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/AS01B vaccine; Biological: Placebo
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59ExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/MF59 vaccine; Biological: Placebo
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/AS01B vaccine; Biological: Placebo
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BExperimentalParticipants 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.
Receives: Biological: DNA-HIV-PT123 vaccine; Biological: Bivalent Subtype C gp120/AS01B vaccine; Biological: Placebo
Group 7: Placebo + Protein/AS01BExperimentalParticipants 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.
Receives: Biological: Bivalent Subtype C gp120/AS01B vaccine; Biological: Placebo
Group 8: PlaceboPlacebo comparatorParticipants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented.

    Measured: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

  2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented.

    Measured: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

  3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

    Measured: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6

  4. Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

    For participants reporting multiple AEs over the time frame, the maximum relationship is counted.

    Measured: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

  5. Number of Participants Reporting Adverse Events (AEs), by Severity Grade

    For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

    Measured: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

  6. Number of Participants Reporting Serious Adverse Events (SAEs)

    Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

    Measured: Measured through Month 12

  7. Number of Participants Reporting Adverse Events of Special Interest (AESIs)

    There were no adverse events of special interest reported by any participant.

    Measured: Measured through Month 18

  8. Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)

    There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant.

    Measured: Measured through Month 12

  9. Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

    There were no early study terminations associated with an AE or reactogenicity reported by any participant.

    Measured: Measured through Month 12

  10. Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

    From the study product discontinuation form, study product administration reasons are tabulated by treatment arm.

    Measured: Measured through Month 6.5

  11. Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  12. Chemistry and Hematology Laboratory Measures - Creatinine.

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  13. Chemistry and Hematology Laboratory Measures - Hemoglobin.

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  14. Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  15. Chemistry and Hematology Laboratory Measures - Platelets, WBC.

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  16. Numbers of Participants With Grade 1 or Higher Local Laboratory Results.

    The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint.

    Measured: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

  17. Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.

    IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    Measured: Measured at Month 6.5

  18. Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.

    IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    Measured: Measured at Month 6.5

  19. Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.

    Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    Measured: Measured at Month 6.5

  20. Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.

    Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    Measured: Measured at Month 6.5

  21. Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates.

    The neutralizing antibody assay was not run. Therefore this dataset doesn't exist

    Measured: Measured at Month 6.5

  22. Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.

    PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    Measured: Measured at Month 6.5

  23. Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.

    PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    Measured: Measured at Month 6.5

  24. Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.

    PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    Measured: Measured at Month 6.5

  25. Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.

    PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    Measured: Measured at Month 6.5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion7 Aug 2019
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915016
Sponsor's protocol ID
HVTN 108
Other IDs
12007
Status last verified
Oct 2021
First submitted
22 Sep 2016
Last updated
29 Apr 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40704585

  • 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.

    PubMed 40190112

  • 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.

    PubMed 38916429

  • 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.

    PubMed 34895272

  • 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.

    PubMed 30282622

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DNA-HIV-PT123 vaccine, Bivalent Subtype C gp120/MF59 vaccine and Bivalent Subtype C gp120/AS01B vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 63 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Africa, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness (time frame: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02915016, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

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