Clinical Trial of the PfSPZ Vaccine
Public ClinicalTrials.gov record NCT01001650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2a Trial of the PfSPZ Vaccine Administered Subcutaneously or Intradermally to Malaria-Naïve Adult Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety and tolerability of a non-replicating, metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID) administration. In addition, the investigators wish to evaluate PfSPZ vaccine-mediated protection against P. falciparum challenge in the following 4 groups (see below) and compare protective efficacy of the PfSPZ vaccine when given by SC v ID administration in all these groups: * Group 1: 4 doses of 7,500 PfSPZ/immunization, * Group 2: 4 doses of 30,000 PfSPZ/immunization, * Group 3: 4 doses of 135,000 PfSPZ/immunization * Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization. If \> 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will receive a fifth and sixth dose.
Study identification
- NCT ID
- NCT01001650
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2009
- Primary completion
- Jun 30, 2010
- Completion
- Aug 31, 2010
- Last update posted
- Sep 9, 2014
2009 – 2010
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Center for Vaccine Development, University of Maryland (CVD/UMB) | Baltimore | Maryland | 21201 | — |
| Naval Medical Research Center (NMRC) Clinical Trials Center, on the campus of the National Naval Medical Center (NNMC) | Bethesda | Maryland | 20889-5607 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01001650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2014 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01001650 live on ClinicalTrials.gov.