AzTrials
AzTrials

HIV InfectionsPhase 1NCT02296541

Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults

A Phase 1 study testing DNA Nat-B env, DNA CON-S env and DNA Mosaic env in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults. 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?
DNA Nat-B env, DNA CON-S env and DNA Mosaic env
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
7 sitesin 2 countries
Study dates
Dec 2014to 6 Jul 2020
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
  • Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years for U.S. participants (5 years for participants in Switzerland) following initial study injection
  • Agrees not to enroll in another study of an investigational research agent
Show all 37Show fewer
  • 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 12.5 g/dL for participants who were born female, greater than or equal to 13.5 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), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to the institutional upper limit of normal
  • Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal
  • Virology
  • Negative HIV-1 and -2 blood test: U.S. participants must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. site 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
  • Participants who were born female: negative serum or urine beta human chorionic gonadotropin (beta-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: participants who were born female must:
  • Agree to consistently use effective contraception (information on effective contraception methods can be found in the protocol) 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.
  • 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
  • Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 106 study
  • Pregnant or breastfeeding
Show all 44Show fewer
  • Vaccines and Other Injections
  • Smallpox vaccine received within the last 5 years
  • HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 106 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis and the identity of the study control/placebo must be obtained.
  • 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 the FDA. For participants who have received control/placebo in an experimental vaccine trial, the HVTN 106 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 106 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 or to vaccine components such as neomycin or streptomycin, including 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
  • Immunodeficiency
  • Hypersensitivity to eggs and/or egg products
  • 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 can be found 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 exclusion criteria: Asthma other than mild, well-controlled asthma. More information on this criterion can be found 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 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 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 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.
  • History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
  • Participants who have 2 or more of the following cardiac risk factors:
  • Participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL;
  • First degree relative (e.g., mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
  • Current smoker; or
  • BMI greater than or equal to 35
  • Electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by the contract ECG Lab, cardiologist, or study clinician. More information on this criterion can be found in the protocol.
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
  • 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 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 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

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030

  • Bridge HIV CRS

    San Francisco, California, 94143

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109-1024

Other trials in United States

Switzerland1 site

  • Lausanne Vaccine and Immunotherapy Center CRS

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of 3 Different HIV-1 DNA Priming Regimens (Nat-B Env, CON-S Env, and Mosaic Env) With MVA-CMDR Boosts in Healthy, HIV-1-Uninfected Adults

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.

Read the detailed description

This study will evaluate the safety, tolerability, and immunogenicity to four different HIV vaccines in healthy, HIV-uninfected adults. The vaccines include three DNA vaccines-DNA Nat-B env, DNA CON-S env, and DNA Mosaic env-and a vaccine called MVA-CMDR that may boost the immune response to the DNA vaccines.

The study will enroll healthy, HIV-uninfected participants aged 18 to 50 years. Participants will be randomly assigned to one of three groups and will receive either one of the experimental vaccine regimens or a placebo vaccine regimen. Group 1 participants will receive the DNA Nat-B env and MVA-CMDR vaccines or placebo. Group 2 participants will receive the DNA CON-S env and MVA-CMDR vaccines or placebo. Group 3 participants will receive DNA Mosaic env and MVA-CMDR vaccines or placebo.

All participants will receive one of their assigned vaccines at study entry (Month 0), and Months 1, 2, 4, and 8.

Total study duration will be either 3 years after enrollment (for participants in the United States) or 5 years after enrollment (for participants in Switzerland). For all participants, study visits will occur at study entry (Month 0), and Months 0.5, 1, 1.5, 2, 2.5, 4, 4.5, 8, 8.25, 8.5, 11, 13.75, and 14. After the last study visit, participants will be contacted annually by phone or e-mail for a total of 3 (U.S. participants) or 5 (Switzerland participants) years to answer questions about their health.

All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine and stool collection, HIV testing, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants receiving the MVA-CMDR vaccine, select study visits may also include an assessment of cardiac symptoms.

Conditions
HIV Infections
Being tested
DNA Nat-B env, DNA CON-S env, DNA Mosaic env, MVA-CMDR, Placebo for DNA Nat-B env
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 Nat-B envBiological

    4 mg to be administered as 1 mL intramuscularly (IM) by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • DNA CON-S envBiological

    4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • DNA Mosaic envBiological

    4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • MVA-CMDRBiological

    Also called Modified Vaccinia Virus Ankara (MVA-CMDR)

    1×10^8 plaque forming units (pfu) to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • Placebo for DNA Nat-B envBiological

    Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • Placebo for DNA CON-S envBiological

    Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • Placebo for DNA Mosaic envBiological

    Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

  • Placebo for MVA-CMDRBiological

    Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Study groups in NCT02296541
Study groupRoleWhat they receive
Group 1: DNA Nat-B env and MVA-CMDRExperimentalParticipants will receive a single injection of DNA Nat-B env at Months 0, 1, and 2. They will receive a single injection of MVA-CMDR at Months 4 and 8.
Receives: Biological: DNA Nat-B env; Biological: MVA-CMDR
Group 1: Placebo vaccines for DNA Nat-B env and MVA-CMDRPlacebo comparatorParticipants will receive a single injection of placebo for DNA Nat-B env at Months 0, 1, and 2. They will receive a single injection of placebo for MVA-CMDR at Months 4 and 8.
Receives: Biological: Placebo for DNA Nat-B env; Biological: Placebo for MVA-CMDR
Group 2: DNA CON-S env and MVA-CMDRExperimentalParticipants will receive a single injection of DNA CON-S env at Months 0, 1, and 2. They will receive a single injection of MVA-CMDR at Months 4 and 8.
Receives: Biological: DNA CON-S env; Biological: MVA-CMDR
Group 2: Placebo vaccines for DNA CON-S env and MVA-CMDRPlacebo comparatorParticipants will receive a single injection of placebo for DNA CON-S env at Months 0, 1, and 2. They will receive a single injection of placebo for MVA-CMDR at Months 4 and 8.
Receives: Biological: Placebo for DNA CON-S env; Biological: Placebo for MVA-CMDR
Group 3: DNA Mosaic env and MVA-CMDRExperimentalParticipants will receive a single injection of DNA Mosaic env at Months 0, 1, and 2. They will receive a single injection of MVA-CMDR at Months 4 and 8.
Receives: Biological: DNA Mosaic env; Biological: MVA-CMDR
Group 3: Placebo vaccines for DNA Mosaic env and MVA-CMDRPlacebo comparatorParticipants will receive a single injection of placebo for DNA Mosaic env at Months 0, 1, and 2. They will receive a single injection of placebo for MVA-CMDR at Months 4 and 8.
Receives: Biological: Placebo for DNA Mosaic env; Biological: Placebo for MVA-CMDR

What is being measured

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

  1. Frequency of local and systemic injection site reactogenicity signs and symptoms for each type of vaccine

    Measured: Measured through Month 8

  2. Severity of local and systemic injection site reactogenicity signs and symptoms for each type of vaccine

    Measured: Measured through Month 8

  3. Frequency of adverse events (AEs)

    Categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products; detailed description of all AEs meeting Division of AIDS (DAIDS) criteria for expedited reporting (EAE)

    Measured: Measured through participant follow-up (3 and 5 years for participants in the United States and Switzerland, respectively)

  4. Laboratory measure of safety: measurement of white blood cells (WBC)

    Measured: Measured through Month 8

  5. Laboratory measure of safety: measurement of neutrophils

    Measured: Measured through Month 8

  6. Laboratory measure of safety: measurement of lymphocytes

    Measured: Measured through Month 8

  7. Laboratory measure of safety: measurement of hemoglobin

    Measured: Measured through Month 8

  8. Laboratory measure of safety: measurement of platelets

    Measured: Measured through Month 8

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

    Measured: Measured through Month 8

  10. Laboratory measure of safety: measurement of aspartate aminotransferase (AST)

    Measured: Measured through Month 8

  11. Laboratory measure of safety: measurement of alkaline phosphatase

    Measured: Measured through Month 8

  12. Laboratory measure of safety: measurement of creatinine

    Measured: Measured through Month 8

  13. Number of participants with early discontinuation of vaccinations and reason for discontinuation

    Measured: Measured through Month 8

Secondary outcomes (18)

  1. Response rate of CD4 T-cell responses 2 weeks after the last DNA vaccination

    Measured by intracellular cytokine staining (ICS) to the Center for HIV/AIDS Vaccine Immunology (CHAVI) and PTEg peptide pools

    Measured: Measured through Month 2.5

  2. Total magnitude of CD4 T-cell responses 2 weeks after the last DNA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 2.5

  3. Response rate of CD8 T-cell responses 2 weeks after the last DNA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 2.5

  4. Total magnitude of CD8 T-cell responses 2 weeks after the last DNA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 2.5

  5. Breadth of CD4 T-cell responses determined by epitope mapping, 2 weeks after the last DNA vaccination

    Breadth determined as the number of reactive epitopes to the CHAVI and PTEg peptide pools

    Measured: Measured through Month 2.5

  6. Breadth of CD8 T-cell responses determined by epitope mapping, 2 weeks after the last DNA vaccination

    Breadth determined as the number of reactive epitopes to the CHAVI and PTEg peptide pools

    Measured: Measured through Month 2.5

  7. Response rate of CD4 T-cell responses 2 weeks after each MVA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 8.5

  8. Total magnitude of CD4 T-cell responses 2 weeks after each MVA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 8.5

  9. Response rate of CD8 T-cell responses 2 weeks after each MVA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 8.5

  10. Total magnitude of CD8 T-cell responses 2 weeks after each MVA vaccination

    Measured by ICS to CHAVI and PTEg peptide pools

    Measured: Measured through Month 8.5

  11. Breadth of CD4 T-cell responses determined by epitope mapping, 2 weeks after MVA vaccination

    Breadth determined as the number of reactive epitopes to the CHAVI peptide pools and to PTEg peptide pools

    Measured: Measured through Month 8.5

  12. Breadth of CD8 T-cell responses determined by epitope mapping, 2 weeks after MVA vaccination

    Breadth determined as the number of reactive epitopes to the CHAVI peptide pools and to PTEg peptide pools

    Measured: Measured through Month 8.5

  13. Magnitude of HIV-specific binding immunoglobulin G (IgG) Env antibody (Ab) responses 2 weeks after the last MVA vaccination

    Determined by binding Ab multiplex assay (BAMA) and, for a subset, peptide array

    Measured: Measured through Month 8.5

  14. Breadth of HIV-specific binding IgG Env Ab responses 2 weeks after the last MVA vaccination

    Determined by BAMA and, for a subset, peptide array

    Measured: Measured through Month 8.5

  15. Magnitude of HIV-specific binding immunoglobulin A (IgA) Env Ab responses 2 weeks after the last MVA vaccination

    Determined by BAMA and, for a subset, peptide array

    Measured: Measured through Month 8.5

  16. Breadth of HIV-specific binding IgA Env Ab responses 2 weeks after the last MVA vaccination

    Determined by BAMA and, for a subset, peptide array

    Measured: Measured through Month 8.5

  17. Magnitude of serum neutralizing antibodies (nAbs) to a panel of standardized HIV-1 isolates

    Measured: Measured through Month 14

  18. Breadth of serum nAbs to a panel of standardized HIV-1 isolates

    Measured: Measured through Month 14

Timeline

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

  1. First posted20 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionNov 2016
  4. Study completion6 Jul 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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296541
Sponsor's protocol ID
HVTN 106
Other IDs
11999
Status last verified
Apr 2023
First submitted
18 Nov 2014
Last updated
24 Apr 2023
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

  • Cohen KW, Fiore-Gartland A, Walsh SR, Yusim K, Frahm N, Elizaga ML, Maenza J, Scott H, Mayer KH, Goepfert PA, Edupuganti S, Pantaleo G, Hutter J, Morris DE, De Rosa SC, Geraghty DE, Robb ML, Michael NL, Fischer W, Giorgi EE, Malhi H, Pensiero MN, Ferrari G, Tomaras GD, Montefiori DC, Gilbert PB, McElrath MJ, Haynes BF, Korber BT, Baden LR; NIAID HVTN 106 Study Group. Trivalent mosaic or consensus HIV immunogens prime humoral and broader cellular immune responses in adults. J Clin Invest. 2023 Feb 15;133(4):e163338. doi: 10.1172/JCI163338.

    PubMed 36787249

  • Campion SL, Brenna E, Thomson E, Fischer W, Ladell K, McLaren JE, Price DA, Frahm N, McElrath JM, Cohen KW, Maenza JR, Walsh SR, Baden LR, Haynes BF, Korber B, Borrow P, McMichael AJ. Preexisting memory CD4+ T cells contribute to the primary response in an HIV-1 vaccine trial. J Clin Invest. 2021 Dec 1;131(23):e150823. doi: 10.1172/JCI150823.

    PubMed 34850742

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DNA Nat-B env, DNA CON-S env and DNA Mosaic env in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 37 inclusion and 44 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 24 Apr 2023. 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, Switzerland. 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 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 injection site reactogenicity signs and symptoms for each type of vaccine (time frame: Measured through Month 8). The study lists 13 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 NCT02296541, which also lists 3 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 24 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in