To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative WomenPhase 2CAPRISA 012CNCT07810062
A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women
A Phase 2 study testing Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS in people with To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women
- What is being tested?
- Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 990 participants
- Where
- 1 siteZambia
- Study dates
- 28 Aug 2023to 30 Jun 2025
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 30 years of age Persons born Female (assigned female sex at birth) and identifying as female.Able and willing to complete the informed consent process
- Able to understand the information provided including the potential impact and/or risks linked to SC administration of the study product, willing to comply with protocol procedures, has access to the clinical research site and is available for follow-up for the study duration
- Based on clinical assessment, participant must be in good general health as per opinion of the Principal Investigator (PI) or designee
- Haemoglobin > 10g/dl
- Creatinine ≤ 1.25 x ULN
- ALT < 1.25 x ULN
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- HIV negative
- Negative β-HCG (human chorionic gonadotropin) pregnancy test on day of enrolment
- If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period
- Sexually active in the last 3 months
Who cannot join
- Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant
- If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding
- A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance
- Prior participation in an investigational HIV vaccine trial, except if proof of allocation to the placebo arm is available.
- Receipt of any vaccines within 28 days prior to enrolment
- Administration of a monoclonal antibody or polyclonal immunoglobulin within 6 months prior to enrolment
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- Investigational HIV-related products received within 6 months prior to enrolment
- Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema
- Evidence of autoimmune disease or currently receiving immunosuppressive therapy
- Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV Negative Women
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women
Read the detailed description
STUDY SCHEMA
Purpose:
To assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS monoclonal antibodies in HIV-negative women
Study design:
A double blinded, randomized, placebo-controlled phase II trial
Rationale :
Current pharmacokinetic data on CAP256V2LS and VRC07.523LS suggest that plasma antibody concentrations projected out to 120 days and 180 days are above 1 μg/ml. In the macaque model, all animals were protected from challenge at CAP256-VRC26.25-LS plasma concentrations as low as <0.75 μg/ml. CAP256-VRC26.25-LS was fully protective even at the 0.08 mg/kg dose.
In the absence of a plasma antibody concentration that correlates with protection in humans, this dose-ranging phase II trial will assess safety of CAP256V2LS and VRC07.523LS administered at 4-monthly and 6-monthly dosing intervals, using antibody concentrations and breakthrough HIV infections, if any to guide dose and dosing interval selections for the future phase III trial.
Study participants: HIV negative (N=984) 18 to 30 years.
Study sites:
- CAPRISA eThekwini Clinical Research Site, Durban, KwaZulu-Natal, South Africa
- CAPRISA Vulindlela Clinical Research Site, Howick, KwaZulu-Natal, South Africa
- The Centre for Infectious Disease Research in Zambia (CIDRZ): Matero Clinical Research Site, Lusaka, Zambia
Study duration :
Enrolment will take place within 56 days of screening.
- Participants will receive study product at 24-week (6-monthly) or 16-week (4-monthly) intervals.
- Depending on the dosing interval, participants will continue in follow up until approximately 16, 18 or 20 months.
Study products: CAP256V2LS and VRC07-523LS administered as separate injections
Primary objective:
- To evaluate the safety of CAP256V2LS and VRC07-523LS in HIV-negative women
Secondary objectives:
- To evaluate the tolerability of CAP256V2LS and VRC07-523LS
- To assess the PK profile of study products administered 16 weekly (4 monthly) in comparison to 24 weekly (6 monthly) administration
- To compare HIV incidence rates in antibody and placebo recipients
- To assess CAP256V2LS and VRC07-523LS systemic and mucosal concentrations in relation to breakthrough infections
- To determine the prevalence of autoantibody induction
- To assess participant acceptability of the subcutaneous injections
- Being tested
- Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
- Keywords
- HIV Prevention, broadly neutralising antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LSBiological
HIV prevention
| Study group | Role | What they receive |
|---|---|---|
| CAP256V2LS and VRC07- 523LS | Experimental | Assign individual study participants to one of the two study arms within a 4- and 6- monthly dosing schedule- two doses. Receives: Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS |
| Normal saline | Placebo comparator | Normal saline SC at 16 or 24week (4 or 6 monthly) dosing intervals Receives: Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days and adverse events after administration of CAP256V2LS in combination with VRC07-523LS
The aim of the CAPRISA 012C trial is to assess extended safety and obtain an estimate of efficacy in preventing HIV infection in young women by measuring
- Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS
- Proportion of participants with any grade 3 or higher adverse events related to the administration of CAP256V2LS in combination with VRC07-523LS
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start28 Aug 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Model description
- Current pharmacokinetic data on CAP256V2LS and VRC07.523LS suggest that plasma antibody concentrations projected out to 120 days and 180 days are above 1 μg/ml. In the macaque model, all animals were protected from challenge at CAP256-VRC26.25-LS plasma concentrations as low as \<0.75 μg/ml. CAP256-VRC26.25-LS was fully protective even at the 0.08 mg/kg dose. In the absence of a plasma antibody concentration that correlates with protection in humans, this dose-ranging phase II trial will assess safety of CAP256V2LS and VRC07.523LS administered at 4-monthly and 6-monthly dosing intervals, using antibody concentrations and breakthrough HIV infections, if any to guide dose and dosing interval selections for the future phase III trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Medical Research Council, South Africa, University of Cape Town, Amsterdam Institute for Global Health and Development, Centre for the AIDS Programme of Research in South Africa, National Institute of Communicable Diseases - NICD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810062
- Sponsor's protocol ID
- CAPRISA 2542-2022
- Acronym
- CAPRISA 012C
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Placebo-controlled Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV Negative Women
- ClinicalTrials.gov ID
- NCT07810062
- Acronym / sponsor ID
- CAPRISA 012C / CAPRISA 2542-2022
- Keywords
- HIV Prevention, broadly neutralising antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Medical Research Council, South Africa, University of Cape Town, Amsterdam Institute for Global Health and Development, Centre for the AIDS Programme of Research in South Africa, National Institute of Communicable Diseases - NICD
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women
Detailed description
STUDY SCHEMA
Purpose:
To assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS monoclonal antibodies in HIV-negative women
Study design:
A double blinded, randomized, placebo-controlled phase II trial
Rationale :
Current pharmacokinetic data on CAP256V2LS and VRC07.523LS suggest that plasma antibody concentrations projected out to 120 days and 180 days are above 1 μg/ml. In the macaque model, all animals were protected from challenge at CAP256-VRC26.25-LS plasma concentrations as low as <0.75 μg/ml. CAP256-VRC26.25-LS was fully protective even at the 0.08 mg/kg dose.
In the absence of a plasma antibody concentration that correlates with protection in humans, this dose-ranging phase II trial will assess safety of CAP256V2LS and VRC07.523LS administered at 4-monthly and 6-monthly dosing intervals, using antibody concentrations and breakthrough HIV infections, if any to guide dose and dosing interval selections for the future phase III trial.
Study participants: HIV negative (N=984) 18 to 30 years.
Study sites:
- CAPRISA eThekwini Clinical Research Site, Durban, KwaZulu-Natal, South Africa
- CAPRISA Vulindlela Clinical Research Site, Howick, KwaZulu-Natal, South Africa
- The Centre for Infectious Disease Research in Zambia (CIDRZ): Matero Clinical Research Site, Lusaka, Zambia
Study duration :
Enrolment will take place within 56 days of screening.
- Participants will receive study product at 24-week (6-monthly) or 16-week (4-monthly) intervals.
- Depending on the dosing interval, participants will continue in follow up until approximately 16, 18 or 20 months.
Study products: CAP256V2LS and VRC07-523LS administered as separate injections
Primary objective:
- To evaluate the safety of CAP256V2LS and VRC07-523LS in HIV-negative women
Secondary objectives:
- To evaluate the tolerability of CAP256V2LS and VRC07-523LS
- To assess the PK profile of study products administered 16 weekly (4 monthly) in comparison to 24 weekly (6 monthly) administration
- To compare HIV incidence rates in antibody and placebo recipients
- To assess CAP256V2LS and VRC07-523LS systemic and mucosal concentrations in relation to breakthrough infections
- To determine the prevalence of autoantibody induction
- To assess participant acceptability of the subcutaneous injections
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Current pharmacokinetic data on CAP256V2LS and VRC07.523LS suggest that plasma antibody concentrations projected out to 120 days and 180 days are above 1 μg/ml. In the macaque model, all animals were protected from challenge at CAP256-VRC26.25-LS plasma concentrations as low as <0.75 μg/ml. CAP256-VRC26.25-LS was fully protective even at the 0.08 mg/kg dose. In the absence of a plasma antibody concentration that correlates with protection in humans, this dose-ranging phase II trial will assess safety of CAP256V2LS and VRC07.523LS administered at 4-monthly and 6-monthly dosing intervals, using antibody concentrations and breakthrough HIV infections, if any to guide dose and dosing interval selections for the future phase III trial.
| Arm | Type | Receives |
|---|---|---|
| CAP256V2LS and VRC07- 523LS | Experimental | Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LSAssign individual study participants to one of the two study arms within a 4- and 6- monthly dosing schedule- two doses. |
| Normal saline | Placebo comparator | Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LSNormal saline SC at 16 or 24week (4 or 6 monthly) dosing intervals |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 to 30 years of age Persons born Female (assigned female sex at birth) and identifying as female.Able and willing to complete the informed consent process
- Able to understand the information provided including the potential impact and/or risks linked to SC administration of the study product, willing to comply with protocol procedures, has access to the clinical research site and is available for follow-up for the study duration
- Based on clinical assessment, participant must be in good general health as per opinion of the Principal Investigator (PI) or designee
- Haemoglobin > 10g/dl
- Creatinine ≤ 1.25 x ULN
Key exclusion criteria (10 listed)
- Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant
- If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding
- A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance
- Prior participation in an investigational HIV vaccine trial, except if proof of allocation to the placebo arm is available.
- Receipt of any vaccines within 28 days prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LSHIV prevention | Biological | CAP256V2LS and VRC07- 523LS, Normal saline |
Primary outcome
Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days and adverse events after administration of CAP256V2LS in combination with VRC07-523LS
Time frame: 18 months
The aim of the CAPRISA 012C trial is to assess extended safety and obtain an estimate of efficacy in preventing HIV infection in young women by measuring * Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS * Proportion of participants with any grade 3 or higher adverse events related to the administration of CAP256V2LS in combination with VRC07-523LS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS in people with To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
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 10 inclusion and 10 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 9 Sep 2026. 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 Zambia. 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?
Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days and adverse events after administration of CAP256V2LS in combination with VRC07-523LS (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.