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HIV InfectionsPhase 1NCT02207920

Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults

A Phase 1 study testing AIDSVAX B/E Vaccine and DNA-HIV-PT123 Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.

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, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
AIDSVAX B/E Vaccine and DNA-HIV-PT123 Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
7 sitesUnited States
Study dates
Jul 2014to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General and Demographic Criteria
  • Access to a participating HIV Vaccine Trials Network (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: participant 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
  • Good general health as shown by medical history, physical exam, and screening laboratory tests
Show all 35Show fewer
  • 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 participants who were born female; greater than or equal to 13.0 g/dL for participants 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: alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal (IULN) and creatinine less than or equal to IULN
  • Virology
  • Negative HIV-1 and -2 blood test: participants must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA)
  • Negative hepatitis B surface antigen (HBsAg)
  • Negative anti-hepatitis C virus (anti-HCV) Abs, 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 cell levels within institutional normal range)
  • Reproductive Status
  • Participants 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 with bilateral oophorectomy (verified by medical records) are not required to undergo pregnancy testing.
  • Reproductive status: a participant who was born female must:
  • Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit;
  • 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. More information on this criterion is available in the protocol.
  • Participants 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

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: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or known hyperlipidemia
  • Intent to participate in another study of an investigational research agent before the last required protocol clinic visit
  • Pregnant or breastfeeding
Show all 35Show fewer
  • Vaccines and Other Injections
  • HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 105 Protocol Safety Review Team (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 by FDA. For participants who have received control/placebo in an experimental vaccine trial, the HVTN 105 PSRT will determine eligibility on a case-by-case basis. For participants who have received an experimental vaccine(s) more than 5 years ago, eligibility for enrollment will be determined by the HVTN 105 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 (e.g., 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 (e.g., 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 excluded: [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, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child)
  • Immunoglobulin received within 60 days before first vaccination
  • Autoimmune disease (Not excluded: mild, well-controlled psoriasis)
  • 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. More information on this criterion is available in the protocol.
  • 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 participant'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. More information on this criterion is available in the protocol.
  • 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 participant 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 participants, 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 participant 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 (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded: participant 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 the past 3 years. Also exclude if participant 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

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • 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

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • University of Rochester Vaccines to Prevent HIV Infection CRS

    Rochester, New York, 14642

  • Bridge HIV CRS

    San Francisco, California, 94143

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Different Combinations of DNA-HIV-PT123 and AIDSVAX® B/E in Healthy, HIV Uninfected Adult Participants

This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the combination of two different experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-administered in different sequences or simultaneously, in healthy adults who are not infected with HIV.

Participants will be randomly assigned to four groups. Depending on which group participants are in, they will receive different combinations of the DNA-HIV-PT123 vaccine, the AIDSVAX® B/E vaccine, a placebo for DNA-HIV-PT123 vaccine, and/or a placebo for AIDSVAX® B/E vaccine. Study visits will occur at study entry, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. All participants will receive their assigned combinations of vaccines at study entry and Months 1, 3, and 6. At each vaccination visit, participants will receive one injection in each upper arm. Following each vaccination, participants will remain in the clinic for 30 minutes for monitoring. All study visits will include a physical examination, HIV risk reduction counseling, and questionnaires and assessments. Select study visits will also include a urine collection, a blood collection, a pregnancy test for participants who were born female, and HIV testing and counseling.

Conditions
HIV Infections
Being tested
AIDSVAX B/E Vaccine, DNA-HIV-PT123 Vaccine, Placebo for DNA-HIV-PT123, Placebo for AIDSVAX B/E
Medical subject headings
HIV Infections

What participants receive

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

  • AIDSVAX B/E VaccineBiological

    600 mcg/mL to be administered as 1 mL intramuscular (IM) injection

  • DNA-HIV-PT123 VaccineBiological

    4 mg/mL to be administered as 1 mL IM injection

  • Placebo for DNA-HIV-PT123Biological

    Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection

  • Placebo for AIDSVAX B/EBiological

    Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection

Study groups in NCT02207920
Study groupRoleWhat they receive
Group 1ExperimentalAt study entry and Month 1, participants will receive placebo for DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid.
Receives: Biological: AIDSVAX B/E Vaccine; Biological: DNA-HIV-PT123 Vaccine; Biological: Placebo for DNA-HIV-PT123; Biological: Placebo for AIDSVAX B/E
Group 2ExperimentalAt study entry and Month 1, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive placebo for DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Receives: Biological: AIDSVAX B/E Vaccine; Biological: DNA-HIV-PT123 Vaccine; Biological: Placebo for DNA-HIV-PT123; Biological: Placebo for AIDSVAX B/E
Group 3ExperimentalAt study entry and Month 1, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Receives: Biological: AIDSVAX B/E Vaccine; Biological: DNA-HIV-PT123 Vaccine; Biological: Placebo for AIDSVAX B/E
Group 4ExperimentalAt study entry and Months 1, 3, and 6, participants will receive DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Receives: Biological: AIDSVAX B/E Vaccine; Biological: DNA-HIV-PT123 Vaccine

What is being measured

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

  1. Frequency of local and systemic reactogenicity signs and symptoms

    Measured: Measured through Month 12

  2. Laboratory measure of safety: measurement of complete blood count (CBC)

    Including differential and platelets

    Measured: Measured through Month 12

  3. Laboratory measure of safety: measurement of alanine aminotransferase (ALT)

    Measured: Measured through Month 12

  4. Laboratory measure of safety: measurement of creatinine

    Measured: Measured through Month 12

  5. Frequency of adverse events (AEs)

    Measured: Measured through Month 12

  6. Frequency of serious adverse events (SAEs)

    Measured: Measured through Month 12

  7. HIV-specific binding antibody (Ab) response as assessed by binding Ab multiplex assay

    Measured: Measured 2 weeks after the 4th vaccination

  8. Response rate and magnitude of CD4 T cell responses as assessed by intracellular cytokine staining (ICS) assays

    Measured: Measured 2 weeks after the 4th vaccination

  9. Response rate and magnitude of CD8 T cell responses as assessed by ICS assays

    Measured: Measured 2 weeks after the 4th vaccination

Secondary outcomes (2)

  1. Neutralizing antibody (nAb) magnitude and breadth against tier 1 and tier 2 HIV-1 isolates as assessed by area under the magnitude-breadth curves

    Measured: Measured 2 weeks after the 4th vaccination

  2. Measurement of HIV-specific Ab and T-cell responses

    Measured: Measured 6 months after the 4th vaccination

Timeline

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

  1. First posted4 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207920
Sponsor's protocol ID
HVTN 105
Other IDs
11986
Status last verified
Oct 2021
First submitted
31 Jul 2014
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Basu M, Fucile C, Piepenbrink MS, Bunce CA, Man LX, Liesveld J, Rosenberg AF, Keefer MC, Kobie JJ. Mixed Origins: HIV gp120-Specific Memory Develops from Pre-Existing Memory and Naive B Cells Following Vaccination in Humans. AIDS Res Hum Retroviruses. 2023 Jul;39(7):350-366. doi: 10.1089/AID.2022.0104. Epub 2023 Mar 22.

    PubMed 36762930

  • Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov.

    PubMed 34843602

  • Basu M, Piepenbrink MS, Francois C, Roche F, Zheng B, Spencer DA, Hessell AJ, Fucile CF, Rosenberg AF, Bunce CA, Liesveld J, Keefer MC, Kobie JJ. Persistence of HIV-1 Env-Specific Plasmablast Lineages in Plasma Cells after Vaccination in Humans. Cell Rep Med. 2020 May 19;1(2):100015. doi: 10.1016/j.xcrm.2020.100015.

    PubMed 32577626

  • Rouphael NG, Morgan C, Li SS, Jensen R, Sanchez B, Karuna S, Swann E, Sobieszczyk ME, Frank I, Wilson GJ, Tieu HV, Maenza J, Norwood A, Kobie J, Sinangil F, Pantaleo G, Ding S, McElrath MJ, De Rosa SC, Montefiori DC, Ferrari G, Tomaras GD, Keefer MC; HVTN 105 Protocol Team and the NIAID HIV Vaccine Trials Network. DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial. J Clin Invest. 2019 Nov 1;129(11):4769-4785. doi: 10.1172/JCI128699.

    PubMed 31566579

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AIDSVAX B/E Vaccine and DNA-HIV-PT123 Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.

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 35 inclusion and 35 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of local and systemic reactogenicity signs and symptoms (time frame: Measured through Month 12). The study lists 9 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 NCT02207920, 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 15 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.

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