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HIV InfectionsPhase 2PrEPVaccNCT04066881

A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

A Phase 2 study testing Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48) and Experimental PrEP:TAF/FTC once daily (weeks 0-26) in people with HIV Infections, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.

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

This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. 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?
Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48) and Experimental PrEP:TAF/FTC once daily (weeks 0-26)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,512 participants
Where
1 siteUganda
Study dates
15 Dec 2020to 31 Dec 2024
Phase
Phase 2
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • HIV uninfected adults aged between 18 and 40 years old on the day of screening
  • Willing and able to provide informed consent prior to participation
  • Willing and able to comply with the visit schedule and provide blood, urine and other samples at the required time points
  • Home address accessible for visiting and intending to remain within the recruitment area for at least 82 weeks from screening
  • Likely to be at risk from exposure to HIV during follow up
  • Willing to undergo HIV testing, receive HIV test results and risk reduction counselling which includes promotion of PrEP and condoms
  • If female, of child-bearing age and not sterilised, willing to use a highly effective method of contraception from screening until 18 weeks after the last injection
  • If male and not sterilised, willing to avoid impregnating female partners from screening until 18 weeks after the last injection

Who cannot join

  • HIV infection or indeterminate HIV result at screening or enrolment
  • Hepatitis B surface antigen positive
  • If female, currently pregnant (evidence from positive serum or urine pregnancy test), or lactating
  • Participating in another biomedical research study or in receipt of a live vaccine within 30 days prior to randomisation
  • Participation in a previous HIV vaccine or HIV immunotherapy trial
  • Receiving blood products or immunoglobulins within 12 weeks of screening
Show all 9Show fewer
  • Known hypersensitivity to any component of the vaccine formulations used in this trial or history of severe or multiple allergies to vaccines, drugs or pharmaceutical agents
  • Presence of a systemic disease at the time of randomisation or history of chronic illness that in the opinion of the investigator may compromise the participant's safety, preclude vaccination or compromise an immune response to vaccine
  • Abnormalities in routine laboratory parameters (Hb, creatinine, AST/ALT, alkaline phosphatase, total Bilirubin and glucose) of Grade 2 and above using the DAIDS toxicity table, version 2.1 July 2017 or estimated glomerular filtration rate less than 50ml/min

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • MRC/UVRI and LSHTM Uganda Research Unit

    Entebbe

Other trials in Uganda

About this study

Official title: A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis

This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis.

The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment.

Read more

The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.

The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

Read the detailed description

This international, multi-centre, double-blind vaccine study will be a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control.

Pre-screening for risk and HIV status will take place as part of a Registration Cohort which will precede and continue in parallel to the PrEPVacc trial enrolments. This will give HIV negative volunteers time to learn about the PrEPVacc trial and facilitate timely enrolment.

Clinical screening for the vaccine trial will take place during the 8 weeks prior to randomisation from local communities in Mozambique, South Africa, Tanzania and Uganda where the clinical research centres are located. Eligible participants who are HIV-uninfected adults aged 18-40 years at high risk of HIV infection will be enrolled at week 0 and randomised to one of three vaccine arms:

  1. Vaccine group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)
  2. Vaccine group B: DNA-HIV-PT123 and CN54gp140 in MPLA-L (wks 0,4), then MVA-CMDR and CN54gp140 in MPLA-L (wks 24,48)
  3. Vaccine group C: Saline Placebo (wks 0,4,24,48)

There will be a concurrent open-label 1:1 randomisation to one of two PrEP regimens:

  1. Control PrEP: Daily TDF/FTC (week 0-26)
  2. Experimental PrEP: Daily TAF/FTC (week 0-26)

Participants will be randomised at each clinical centre through web randomisation after entering the quantifiable eligibility criteria. Randomisation will be stratified by centre and by gender for vaccines and for PrEP. Clinic staff and participants will be blind to allocation of active or placebo vaccines, but the pharmacist preparing the vaccines will know. As the volume of gp140 in MPLA-L is 0.4ml and given at the same timepoints as products with a volume of 1ml, clinic staff will be able to identify participants allocated to the CN54gp140 in MPLA-L or matched placebo.

Clinic staff and participants will know which PrEP agent each participant is allocated to. Participants will continue to receive study PrEP through to week 26 after which access to PrEP will revert to local supply of generic drug.

The target accrual is around 1668 HIV uninfected adults, but this is an endpoint driven multi-arm, multi-stage (MAMS) trial design, and therefore the target may be adjusted following a recommendation from the IDMC. In addition, participants who do not complete the third immunisation will be replaced whilst this is feasible. Participants will be followed up for a minimum of 74 weeks after enrolment.

The primary efficacy outcome measure for the vaccine analysis is HIV acquisition by a participant who completed three immunisations and was HIV negative at week 26.

The primary efficacy outcome for the PrEP analysis is HIV acquisition at or before week 26 by a participant who was HIV negative at enrolment.

The primary safety outcome for both analyses is a clinical decision to discontinue the vaccine or PrEP regimen for an adverse event that is considered related to product.

This trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.

The PrEP component of the trial aims to show the effectiveness of TAF/FTC is not unacceptably lower than the effectiveness of TDF/FTC, assessed from the observed lower confidence limit for the Averted Infections Ratio (AIR).

The Independent Data Monitoring Committee will review an interim analysis of vaccine efficacy in order to determine whether each active vaccine arm has demonstrated sufficient efficacy to warrant further investigation. This analysis will only consider new infections arising after the week 26 visit and only those in individuals who have completed the first three immunisations. The analysis will take place after approximately 7 of these infections have occurred in the placebo group. The investigators will not be informed of the timing of the interim analysis, unless there is a recommendation to modify the protocol.

The PrEP analysis will consider new infections up to the week 26 visit in individuals who were HIV negative at enrolment.

To enhance understanding of the trial results within their broader context, indepth interviews and group discussions with trial participants, as well as structured debriefs with study staff, will be conducted throughout the trial (week 0-74). These activities will examine risk and adherenvce behaviours, along with knowledge, attitudes and perceptions of participants, study staff and wider community.

Conditions
HIV Infections
Being tested
Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Vaccine Group C: Saline placebo (weeks 0,4,24,48), Control PrEP:TDF/FTC once daily (weeks 0-26), Experimental PrEP:TAF/FTC once daily (weeks 0-26)
Keywords
HIV, Vaccine, Pre-exposure prophylaxis, Africa
Medical subject headings
HIV Infections

What participants receive

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

  • Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)Biological

    1. DNA-HIV-PT123 HIV vaccine includes three DNA plasmids that encode clade C ZM96 Gag, clade C ZM96 Env, and CN54 Pol-Nef.
    2. AIDSVAX® B/E is a bivalent HIV gp120 glycoprotein encompassing both subtype B (MN) and subtype E (A244) proteins that are adsorbed onto 600mcg of aluminum hydroxide gel suspension as adjuvant.

  • Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48)Biological

    1. DNA-HIV-PT123 (see above)
    2. CN54gp140+MPLA-L. Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity.
    3. MVA-CMDR (Modified Vaccinia Ankara-Chiang Mai Double Recombinant) is a non-replicating, highly attenuated strain of Vaccina virus that has been genetically engineered to express the HIV-1 genes envgp160 CM235 Subtype E and gag and pol CM240 Subtype A (integrase-deleted and reverse transcriptase non-functional).

  • Vaccine Group C: Saline placebo (weeks 0,4,24,48)Biological

    Sodium Chloride (NaCl) for injection, 0.9%

  • Control PrEP:TDF/FTC once daily (weeks 0-26)Drug

    Also called Truvada

    Each tablet of Truvada contains 245mg of tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.

  • Experimental PrEP:TAF/FTC once daily (weeks 0-26)Drug

    Also called Descovy

    Each tablet of Descovy contains 25mg of tenofovir alfenamide (TAF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.

Study groups in NCT04066881
Study groupRoleWhat they receive
Group AExperimental278 participants will receive DNA-HIV-PT123 vaccine and AIDSVAX® B/E protein at weeks 0, 4, 24 and 48. 1ml of DNA-HIV-PT123 will be injected into the deltoid muscle of the left upper arm 1ml of AIDSVAX® B/E will be injected into the deltoid muscle of the right arm 1 tab of Truvada (0-26 weeks)
Receives: Biological: Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48); Drug: Control PrEP:TDF/FTC once daily (weeks 0-26)
Group BExperimental278 participants will receive DNA-HIV-PT123 and CN54gp140+MPLA-L at weeks 0 and 4, then MVA and CN54gp140+MPLA-L at weeks 24 and 48 1ml of DNA-HIV-PT123 will be injected into the deltoid muscle of the left upper arm 1ml (1x108 pfu) of MVA will be injected into the deltoid muscle of the left upper arm 0.4mL containing a mixture of 100mcg CN54gp140 and 5mcg MPLA-L will be injected into the deltoid muscle of the right upper arm 1 tab of Truvada (0-26 weeks)
Receives: Biological: Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48); Drug: Control PrEP:TDF/FTC once daily (weeks 0-26)
Group C:Placebo comparator278 participants will receive Sodium Chloride 0.9% (Normal Saline) placebo at weeks 0,4,24, and 48 The volume will be matched to the vaccine at 1ml for DNA, MVA and AIDSVAX® B/E, but 0.4ml for CN54gp140 in MPLA-L. Participants will be randomly divided in a 1:1 ratio to receive 1ml in each arm at the four timepoints or 1ml in the left arm and 0.4ml in the right arm at the four timepoints. 1 tab of Truvada (0-26 weeks)
Receives: Biological: Vaccine Group C: Saline placebo (weeks 0,4,24,48); Drug: Control PrEP:TDF/FTC once daily (weeks 0-26)
Group DActive comparator278 participants will receive DNA-HIV-PT123 vaccine and AIDSVAX® B/E protein at weeks 0, 4, 24 and 48. 1ml of DNA-HIV-PT123 will be injected into the deltoid muscle of the left upper arm 1ml of AIDSVAX® B/E will be injected into the deltoid muscle of the right arm 1 tab of Descovy (0-26 weeks)
Receives: Biological: Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48); Drug: Experimental PrEP:TAF/FTC once daily (weeks 0-26)
Group EExperimental278 participants will receive DNA-HIV-PT123 and CN54gp140+MPLA-L at weeks 0 and 4, then MVA and CN54gp140+MPLA-L at weeks 24 and 48 1ml of DNA-HIV-PT123 will be injected into the deltoid muscle of the left upper arm 1ml (1x108 pfu) of MVA will be injected into the deltoid muscle of the left upper arm 0.4mL containing a mixture of 100mcg CN54gp140 and 5mcg MPLA-L will be injected into the deltoid muscle of the right upper arm 1 tab of Descovy (0-26 weeks)
Receives: Biological: Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48); Drug: Experimental PrEP:TAF/FTC once daily (weeks 0-26)
Group GPlacebo comparator278 participants will receive Sodium Chloride 0.9% (Normal Saline) placebo at weeks 0,4,24, and 48 The volume will be matched to the vaccine at 1ml for DNA, MVA and AIDSVAX® B/E, but 0.4ml for CN54gp140 in MPLA-L. Participants will be randomly divided in a 1:1 ratio to receive 1ml in each arm at the four timepoints or 1ml in the left arm and 0.4ml in the right arm at the four timepoints. 1 tab of Descovy (0-26 weeks)
Receives: Biological: Vaccine Group C: Saline placebo (weeks 0,4,24,48); Drug: Experimental PrEP:TAF/FTC once daily (weeks 0-26)

What is being measured

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

  1. Incident HIV infection

    HIV acquisition by a participant who completed three immunisations and was HIV negative at week 26.

    Measured: after week 26

  2. Incident HIV infection

    HIV acquisition at or before week 26 by a participant who was HIV negative at enrolment

    Measured: week 0-26

  3. A clinical decision to discontinue the vaccine regimen for an adverse event that is considered related to product

    A clinical decision to discontinue the vaccine regimen for an adverse event that is considered related to product

    Measured: week 0-48

  4. A clinical decision to discontinue PrEP regimen for an adverse event that is considered related to product

    A clinical decision to discontinue PrEP regimen for an adverse event that is considered related to product

    Measured: week 0-26

Secondary outcomes (12)

  1. Grade 3 and worse solicited clinical and laboratory adverse events

    Grade 3 and worse solicited clinical and laboratory adverse events

    Measured: week 0-74

  2. Discontinuation or interruption of vaccine regimen

    A clinical decision to discontinue or interrupt the vaccine regimen for an adverse event that is considered related to product

    Measured: week 0-74

  3. Discontinuation or interruption of PrEP

    A clinical decision to discontinue or interrupt the PrEP regimen for an adverse event that is considered related to product

    Measured: week 0-26

  4. Grade 3 and worse solicited clinical and laboratory adverse events

    Grade 3 and worse solicited clinical and laboratory adverse events

    Measured: within 7 days of receiving vaccine injection

  5. Serious adverse events

    Serious adverse events

    Measured: week 0-74

  6. Other clinical and laboratory adverse events

    Other clinical and laboratory adverse events

    Measured: week 0-74

  7. Binding antibodies

    Binding antibodies to Cn54gp140 and AIDSVAX® B/E gp120

    Measured: week 0-74

  8. Resistance mutations to tenofovir and emtricitabine

    Genotypic resistance at HIV seroconversion, focussing on the mutations selected by tenofovir and emtricitabine (codons 65, 70, 184 in reverse transcriptase)

    Measured: week 0-74

  9. Number of PrEP pills missed

    Adherence to PrEP assessed by self-report

    Measured: week 0-26

  10. Tenofovir level in urine

    Adherence to PrEP assessed by results of point of care urine tests

    Measured: week 0-26

  11. Tenofovir level in red blood cells

    Adherence assessed by TFV DP levels measured on DBS in red blood cells

    Measured: week 0-26

  12. Number of PrEP Pills dispensed

    Adherence assessed by total number of PrEP pills dispensed

    Measured: week 0-26

Timeline

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

  1. First posted26 Aug 2019
  2. Study start15 Dec 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: DNA-HIV-PT123/AIDSVAX B/E®/TDF/FTC (Truvada) once daily (wks 0-26) Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (wks 0,4), then MVA-CMDR and CN54gp140+MPLA-L/ TDF/FTC(Truvada) once daily (wks 0-26) Group C: Saline placebo (wks 0,4,24,48)/ TDF/FTC (Truvada) once daily (wks 0-26) Group D: DNA-HIV-PT123/AIDSVAX B/E®/ TAF/FTC (Descovy) once daily (wks 0-26) Group E: DNA-HIV-PT123 and CN54gp140+MPLA-L (wks 0,4), then MVA-CMDR and CN54gp140+MPLA-L/ TAF/FTC (Descovy) once daily (wks 0-26) Group F: Saline placebo (wks 0,4,24,48)/ TAF/FTC (Descovy) once daily (wks 0-26) Group G: Saline placebo (wks 0,4,24,48)/ TAF/FTC (Descovy) once daily (wks 0-26)
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
1,512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066881
Sponsor's protocol ID
RGPK190803
Acronym
PrEPVacc
Status last verified
Jan 2025
First submitted
8 Aug 2019
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The investigators will ensure that optimal use is made of the data generated in this trial through a controlled access approach to data sharing. Access will be controlled to ensure that there is a scientific rationale for the data, that no data are released that could compromise the ongoing trial, that the appropriate consent is in place, that an appropriate agreement is in place for secure transfer and storage, and that resources required to process data release are adequate.

Publications

  • Iseselo MK, Tarimo EAM, Ambikile JS, Lukumay GG, Munseri P, Bakari M, Lyamuya E, Aboud S; PrEPVacc Trial Team. Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania. Trials. 2026 Jul 6. doi: 10.1186/s13063-026-09835-9. Online ahead of print.

    PubMed 42410635

  • Kawuma R, Nakamanya S, Tarimo E, Chimukuche RS, Ambindwile J, Pamba D, Kusemererwa S, Munseri P, Singh N, Dube K, McCormack S, Ruzagira E, Seeley J; PrEPVacc trial team. Understanding trial designs and acceptability of participation in an HIV vaccine trial with concurrent randomisation to oral pre-exposure prophylaxis in East and Southern Africa: a longitudinal qualitative study. Trials. 2026 May 16;27(1):412. doi: 10.1186/s13063-026-09774-5.

    PubMed 42141483

  • McCormack S, Dunn D, Kusemererwa S, Munseri P, Singh N, William W, Mutonyi G, Bern H, Goldwirt L, Kingsley C, Kroidl A, Hansen CH, Ding S, Kawuma R, Amondi M, Bahemuka U, Buma D, Clutterbuck D, Gaffoor Z, Jennings A, Joachim A, Kakande A, Kalanzi B, Kisinda A, Matsoso M, Miller T, Morar N, Musau J, Nabbuto J, Nzuza A, Pamba D, Salomone S, Sithole T, Tarimo E, Woeber K, Chinyenze K, Gray G, Lyamuya E, Bakari M, Aboud S, Maganga L, Doncel G, Seeley J, Weber J, Kaleebu P, Fox J, Ruzagira E; PrEPVacc Study Group. A Comparison of F/TAF and F/TDF as HIV Pre-Exposure Prophylaxis in a Predominantly Cisgender Women Population in East and South Africa: A Randomized, Factorial, Noninferiority Trial. J Acquir Immune Defic Syndr. 2026 Jun 1;101(6):655-662. doi: 10.1097/QAI.0000000000003845.

    PubMed 41650395

  • Ambikile JS, Tarimo EAM, Iseselo MK, Lukumay G, Munseri P, Bakari M, Lyamuya E, Aboud S, Kawuma R, Seeley J. The experience of trial participation disclosure among sex workers in a phase IIb HIV vaccine trial: A qualitative study in urban Tanzania. PLOS Glob Public Health. 2025 Nov 19;5(11):e0005511. doi: 10.1371/journal.pgph.0005511. eCollection 2025.

    PubMed 41259346

  • Chimukuche RS, Shandu L, Zulu S, Khanyile P, Singh N, Gaffoor Z, Kawuma R, McCormack S, Seeley J; PrEPVacc Study Group. HIV risk perception, trust and PrEP adherence among participants in an HIV prevention trial: a qualitative longitudinal study, South Africa. BMJ Open. 2025 Apr 23;15(4):e086742. doi: 10.1136/bmjopen-2024-086742.

    PubMed 40268488

  • Chimukuche RS, Kawuma R, Mahapa N, Mkhwanazi S, Singh N, Siva S, Ruzagira E, Seeley J; PrEPVacc Study Group. Examining oral pre-exposure prophylaxis (PrEP) literacy among participants in an HIV vaccine trial preparedness cohort study. BMC Health Serv Res. 2022 Nov 10;22(1):1336. doi: 10.1186/s12913-022-08730-8.

    PubMed 36357877

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48) and Experimental PrEP:TAF/FTC once daily (weeks 0-26) in people with HIV Infections, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.

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 8 inclusion and 9 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. 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 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?

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?

Incident HIV infection (time frame: after week 26). The study lists 4 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 NCT04066881, which also lists 6 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 22 Jan 2025.

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