Engaging in Collaborative Science
The HVTN believes that collaborative science benefits everyone and is committed to sharing its data and specimens with other researchers. These resources are shared through the HVTN’s auxiliary studies process. The Network invites any investigators who would like to answer research questions related to vaccinology, immunology, or HIV/AIDS and other infectious diseases to submit study proposals. Over the years, the HVTN has collaborated with more than 150 institutions from around the world in conducting scientific research, including auxiliary studies.
Auxiliary studies make the most of the data and samples collected during our clinical trials and also benefit researchers who may not have the resources to collect the required data and specimens on their own but have the curiosity and drive to ask challenging research questions. By encouraging cooperation with investigators near and far, the HVTN ensures that the benefits of its trials extend beyond the scope of finding a safe, globally effective HIV vaccine.
Submitting an Auxiliary Studies Proposal
To submit a proposal, please review all information on this page prior to completing the proposal template. Once completed, email your proposal to vtn.research@hvtn.org. The proposal template requests the information needed for the approval process. To ensure a timely response, please provide all the information it requests and contact us at vtn.research@hvtn.org with any questions. General timeframe and approval process steps are outlined below.
We acknowledge receipt of all submitted proposals in a timely manner and will let you know if we require additional information.
HVTN Auxiliary Studies Committee
The HVTN Auxiliary Studies Committee (ASC) meets twice a month to discuss new and current proposals/studies. The committee meets on the 1st Tuesday and the 3rd Thursday. All new proposals are sent to the committee five business days prior to the next meeting for review.
To ensure that your proposal is reviewed at the next meeting, please submit to vtn.research@hvtn.org at least 6 business days prior to the 1st Tuesday or the 3rd Thursday of every month. If your proposal is submitted within 5 business days of the next meeting, it will be reviewed at the subsequent meeting.
The ASC does a feasibility review, which includes confirming availability of the requested data and specimens. It also determines the study type classification for the proposal by examining how its objectives align with the relevant parent protocol and informed consent form language. “Auxiliary” is the blanket term used to cover three different types of studies (exploratory, ancillary, and sub-studies). The study type determines some of the regulatory requirements for the proposed study.
Auxiliary Study Approval Process
Below is an abbreviated flowchart showing the general approval process for an auxiliary study.
All steps in this process include back and forth between the investigator(s) and the point of contact for that step. These communications can be significant and can require amending your proposal. While the ASC assists in keeping every proposal on track, some reviews, approvals, and finalizations of data and specimen requests can result in long exchanges that are outside of the ASC’s control.
Approval Process Steps
General timeframe
Please note that this sequence and proposal approval timeframe is highly dependent on what is being requested. Some proposals move through this entire process within 2-weeks, while some can take upwards of 6-months. Requests for specimens/data from outside the US generally have more regulatory requirements and thus take longer. There are multiple factors that are outside of the committee’s control, and we cannot accommodate requests for expedited review and approvals.
Additional factors that may affect timeframe
In addition to the above, it is highly recommended that investigators include in their proposal if they are on a timeline due to a grant, schooling, or other factors. The ASC acknowledges that there are sometimes time sensitive requests and will evaluate the feasibility and availability to support these. We ask the investigators to acknowledge that there is no guarantee that our team can meet time sensitive deadlines.
Proposal Submission
- Contact vtn.research@hvtn.org to:
- obtain proposal template
- ask questions about completing it; and
- submit completed proposal
- Investigator will receive an email acknowledging their submission
Auxiliary Studies Committee Review
- Feasibility check
- Assign study type (exploratory, ancillary, sub-study), which determines some of the regulatory requirements
Scientific Approval Process
- Review by Protocol Team Leadership
- May be subject to other protocol-specific reviews
- Investigator will receive a scientific approval email
Regulatory Approval Process
- Investigator will receive an email from HVTN Regulatory with the regulatory requirements
- These may include but are not limited to:
- IRB/EC approval
- Legal agreements (MTAs/DTAs)
Formal Approval
- After all regulatory requirements are complete, requested resources are shared with/approved for use by investigators
- Investigators will receive an approval email from HVTN Regulatory
Important Additional Information
Requests on hold:
- Please note that requests for specimens/data from the Janssen studies, HVTN 117, 118, 705, and 706, are not currently being accepted or fulfilled.
Requesting data/specimens from ongoing clinical trials:
- Data and specimens from ongoing clinical trials are generally not provided for auxiliary studies until the main objectives of the trial are complete.
- Data and specimen availability from ongoing trials is dependent on the discretion of the protocol team and HVTN Executive Management Team.
Additional costs:
- Specimen requesters will be responsible for covering international shipment costs.
Where to get help:
- If you have any questions or are unsure on how to best complete a section on the proposal template, please reach out to vtn.research@hvtn.org for assistance.
Publicly Available Data for phase 2b and smaller studies:
- Some of the information you’re requesting may be publicly available. If it is, you do not need to submit a proposal or go through the auxiliary study review process to access this information. For phase 2b studies, see details outlined below for specific studies. For smaller studies, please visit the Atlas SCHARP portal.
HVTN 502 (Step) is a phase 2b trial evaluating the MRK Ad5 HIV-1 gag/pol/nef vaccine in 3,000 men and women at high risk of HIV in North America, the Caribbean, South America and Australia. All public use data are here.
HVTN 505 is a phase 2b trial evaluating the DNA/rAd5 HIV-1 vaccine in 2,504 men or transgender women who have sex with men in the United States. Data for the primary manuscript are available here. Data for T cell and antibody correlates analyses are available here.
HVTN 702 (Uhambo) is a phase 2b/3 trial evaluating the ALVAC-HIV + subtype C gp120/MF59 vaccine in 5,404 men and women at high risk of HIV in South Africa.
- View data for the primary manuscript are available here.
- Data for correlates analyses are available here.
HVTN 703/HPTN 081 and HVTN 704/HPTN 085 (AMP) are two parallel phase 2b trials evaluating passive infusion of the broadly neutralizing antibody VRC01 in 2,699 at-risk cisgender men and transgender persons in the Americas and Europe and 1,924 at-risk women in sub-Saharan Africa. Data for the primary manuscript are available here. Data for the correlates and sieve analyses are available here.