HealthyNCT00068926
VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
An observational study of Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This protocol will screen healthy normal volunteers for participation in studies of vaccines under development at NIAID's Vaccine Research Center. Of interest are vaccines for: Newly identified infectious diseases such as SARS. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 958 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2003to 29 Jun 2011
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years of age
- Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
- Able and willing to complete the informed consent process.
- Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.
Who cannot join
- Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
- A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
- Known to be pregnant or breast-feeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Alliance for Research and Education - Infectious Diseases, LLC
Annandale, Virginia, 22003
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This protocol will screen healthy normal volunteers for participation in studies of vaccines under development at NIAID's Vaccine Research Center. Of interest are vaccines for:
- Newly identified infectious diseases such as SARS.
- Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus
- Emerging infectious diseases that are more widespread geographically than in the past, such as West Nile virus
- For preventing diseases such as tuberculosis and malaria.
Read more
Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol. Screening begins about 1 to 6 months before the start of the vaccine study. Participants will have a physical examination and health history, including questions about sexual activity and drug use. Over the course of the screening visits, participants will be asked to give urine and blood samples to test for various infections and other medical problems. Women capable of getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will not be enrolled in the study.
At the end of the screening, participants will be informed about which vaccines are currently being tested in clinical trials for which they may be eligible. Once participants enroll in a vaccine study, their participation in the screening protocol ends.
Read the detailed description
STUDY DESIGN: The purpose of the study is to screen potential study volunteers to determine if they are eligible for infectious disease vaccine clinical trials being sponsored by the Vaccine Research Center (VRC) at the NIH Clinical Center. All work will be conducted by the VRC Clinic of the National Institutes of Health or IRB-approved extramural sites that are collaborating with the VRC Clinic. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
SUBJECTS: Approximately 3,000 healthy adults; age 18-70 years.
STUDY DURATION: Duration of participation is variable, and may last from a few weeks to several months for each subject. Study participation is complete when the subject enrolls in a vaccine study, is found to be ineligible for all vaccine studies or declines to participate in any vaccine studies.
STUDY EVALUATIONS: Evaluations usually include history, physical examinations and laboratory tests. Only those evaluations needed to determine eligibility for a particular study will be done. Evaluations other than those described in this protocol may be done if necessary for eligibility for a study. Blood will also be collected for storage.
- Conditions
- Healthy
- Keywords
- Biodefense, Prevention, Emergent, Virus, Immune Response, Healthy Volunteer, HV
- Medical subject headings
- Virus Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study start3 Sep 2003
- Study completion29 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068926
- Sponsor's protocol ID
- 030285
- Other IDs
- 03-I-0285
- Status last verified
- 29 Jun 2011
- First submitted
- 11 Sep 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. doi: 10.1086/319235. Epub 2001 Feb 23.
PubMed 11229834
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
- ClinicalTrials.gov ID
- NCT00068926
- Acronym / sponsor ID
- 030285
- Conditions
- Healthy
- Keywords
- Biodefense, Prevention, Emergent, Virus, Immune Response, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 Sep 2003
- Study completion
- 29 Jun 2011
- First posted
- 11 Sep 2003 (estimated)
- 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.
This protocol will screen healthy normal volunteers for participation in studies of vaccines under development at NIAID's Vaccine Research Center. Of interest are vaccines for:
- Newly identified infectious diseases such as SARS.
- Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus
- Emerging infectious diseases that are more widespread geographically than in the past, such as West Nile virus
- For preventing diseases such as tuberculosis and malaria.
Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol. Screening begins about 1 to 6 months before the start of the vaccine study. Participants will have a physical examination and health history, including questions about sexual activity and drug use. Over the course of the screening visits, participants will be asked to give urine and blood samples to test for various infections and other medical problems. Women capable of getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will not be enrolled in the study.
At the end of the screening, participants will be informed about which vaccines are currently being tested in clinical trials for which they may be eligible. Once participants enroll in a vaccine study, their participation in the screening protocol ends.
Detailed description
STUDY DESIGN: The purpose of the study is to screen potential study volunteers to determine if they are eligible for infectious disease vaccine clinical trials being sponsored by the Vaccine Research Center (VRC) at the NIH Clinical Center. All work will be conducted by the VRC Clinic of the National Institutes of Health or IRB-approved extramural sites that are collaborating with the VRC Clinic. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
SUBJECTS: Approximately 3,000 healthy adults; age 18-70 years.
STUDY DURATION: Duration of participation is variable, and may last from a few weeks to several months for each subject. Study participation is complete when the subject enrolls in a vaccine study, is found to be ineligible for all vaccine studies or declines to participate in any vaccine studies.
STUDY EVALUATIONS: Evaluations usually include history, physical examinations and laboratory tests. Only those evaluations needed to determine eligibility for a particular study will be done. Evaluations other than those described in this protocol may be done if necessary for eligibility for a study. Blood will also be collected for storage.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 to 70 years of age
- Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
- Able and willing to complete the informed consent process.
- Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.
Key exclusion criteria (4 listed)
- Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
- A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
- Known to be pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11229834Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. doi: 10.1086/319235. Epub 2001 Feb 23.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 4 inclusion and 4 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00068926, which also lists 1 linked publication.
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 2 Jul 2017.