General Pre-Trial Screening Protocol for Infectious Diseases Research

NCT06463704 | Recruiting

• 1 other identifier: 2023P000266
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) or Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This general screening protocol will help to determine the eligibility of potential volunteers for any vaccine or therapeutic trials open for recruitment or soon to be opened.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Distribution of demographic variables

  Race, ethnicity, gender and sex at birth

  At enrollment

• Number of participants who subsequently enroll in another study

  The number of participants in the general screening protocol who go on to enroll in another study

  From date of enrollment until the date of enrollment in a subsequent study or up to 52 weeks, whichever comes first

Study Arms (1)

Observational cohort for potential study volunteers

This is a general screening protocol to develop a registry of potential volunteers for our clinical trials. There is no intervention to be administered.

Other: There is no intervention

Interventions

There is no intervention OTHER

There is no intervention

Observational cohort for potential study volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be adults interested in participating in a clinical trial, such as a vaccine or therapeutic study, and particularly for studies conducted as part of the HIV Vaccine Trials Network.

You may qualify if:

• years of age or older at time of consent
• Available to participate for the planned duration of the clinical trials for which screening is being done
• Capable of giving signed informed consent

You may not qualify if:

• A condition, based on clinical judgement, which requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Kathryn E Stephenson, MD, MPH

CONTACT

617-735-4556; kstephen@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 18, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2034
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)