Phase 2
N=59
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
Plasmodium Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT00392015 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
May 2021
Primary outcome: Primary: Part A Dose-Escalation: Number of Participants Who Experienced Any Serious Adverse Events Related To Vaccine Administration — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NMRC-M3V-Ad-PfCA (Biological); NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A Dose-Escalation: Number of Participants Who Experienced Any Serious Adverse Events Related To Vaccine Administration |
0; 0 | — |
| PRIMARY Part B Regimen-Comparison: Number of Participants With Any Serious Adverse Events Related to Vaccine Administration |
0; 0 | — |
| PRIMARY Part B Regimen Comparison: Time to Parasitemia to Assess the Protective Efficacy Against Sporozoite Challenge (Pf, 3D7 Strain) |
12.1; 11.8; 13.37; 12.96 | — |
| SECONDARY Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses |
422; 862; 154; 423 | — |
| SECONDARY Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses in Group 3 |
273; 1303 | — |
| SECONDARY Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-MV-Ad-PfC in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses in Group 4 |
323 | — |
| SECONDARY Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses |
0.210; 0.44; 0.044; 0.086; 0.020; 0.15 | — |
| SECONDARY Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining CD4+ and CD8+ T Cell IFN-γ Responses in Group 3 |
0.030; 0.090; 0.093; 0.216 | — |
| SECONDARY Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-MV-Ad-PfC in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses in Group 4 |
0.039; 0.09 | — |
Summary
The purpose of this study is to determine whether a new investigational malaria vaccine is safe, well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to malaria. The vaccine consists of a modified form of a relatively common virus, adenovirus, that has been rendered incapable of replicating itself and modified to deliver the malaria gene of interest to the body's cells allowing the cell to manufacture the protein encoded by the gene and present it to the body's immune system in a more natural and presumably effective way.
Eligibility Criteria
INCLUSION CRITERIA
- Between the ages of 18-50 (inclusive)
- Negative results of HIV ELISA, HbSAg, anti-HCV antibody, and no other clinically significant abnormal laboratory results from screening.
- Adenovirus serotype 5 (Ad5) titer <1:500
- Able to provide written informed consent.
- Complete an Assessment of Understanding and verbalize an understanding of any questions answered incorrectly.
- In good general health without clinically significant medical history or physical exam abnormalities at screening.
- Willing to continue immunogenicity and clinical follow-ups for one year and telephone or mail (electronic/U.S. Postal) contact as long term safety monitoring provision for an additional four years (totaling five years of participation; immunized volunteers only).
- Male and female participants being immunized and female participants being challenged agree to use effective means of birth control (an FDA approved contraceptive, abstinence) between screening and 60 days following last clinical study visit or able to provide evidence of no reproductive capability.
EXCLUSION CRITERIA
- Have a history of malaria infection, exposure to malaria infection(i.e. you have been to an area that has malaria within the past two years),lived in a country with malaria for more than 5 years or receipt of certain candidate malaria vaccines
- Known immune system disease
- Known blood, heart, liver, kidney disease
- At known significant risk for developing heart disease
- A positive result on HIV testing at screening
- A positive result on Hepatitis B or C testing at screening
- Removal of your spleen
- Taking medication that suppresses the immune system within 30 days of immunization.
- Received or will be receiving another vaccine within 30 days of immunization
- Received blood products (e.g. transfused with blood cells, platelets, plasma or serum) within 120 days of the immunization
- Have had serious adverse reactions to other vaccines including hives, anaphylaxis, respiratory difficulty, tongue/mouth/neck/throat/body swelling or abdominal pain
- Pregnant, breastfeeding, or planning to become pregnant during the next year
- Plan to participate (or have participated in the last 30 days) in any other research study including an investigational drug or device
- Unwilling or unable to participate/complete all study elements
- Evidence of previous infection with adenovirus 5 or prior receipt of an adenovirus containing vaccine.
Data sourced from ClinicalTrials.gov (NCT00392015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.