Plasmodium Falciparum MalariaPhase 1NCT00377494
CS DNA MVA Trial in Mampong, Ghana
A Phase 1 study testing MVA-CSO Vaccine and PfCSP DNA (VCL-2510) Vaccine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2 doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA) given as a "booster." Forty-eight adults in Ghana, ages 18-50 years, will participate for 17 months. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- MVA-CSO Vaccine and PfCSP DNA (VCL-2510) Vaccine
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento Jul 2008
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, 18-50 years of age.
- Available to participate for the duration of the study period.
- HIV seronegative, per written proof of assay collected within four weeks of screening
- Provision of personal (not proxy) agreement to consent to the study.
Who cannot join
- Females who are pregnant or nursing, who plan on becoming pregnant or plan to nurse during the study period, or males who plan on fathering children during the study period.
- Have a history of diabetes or any cardiovascular disorder
- Have hypertension, or current treatment with anti-hypertensives.
- Have a total cholesterol >197.5 mg/dL.
- Have an abnormal EKG (e.g., all kinds of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, A-V node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, or 2 premature ventricular contractions (PVC) in a row, or ST elevation consistent with ischemia).
- Have an abnormal Troponin I level.
Show all 24Show fewer
- Are HIV positive or have any known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy).
- Have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.)
- Have or have had any other illness or condition which, in the investigator's judgment, will substantially increase the risk associated with their participation or will compromise the scientific objectives of the protocol.
- Have eczema/atopic dermatitis or other significant skin condition.
- Have anemia, defined by a hemoglobin level < 12.7g/dl in males, and < 10.5 g/dl in females.
- Have a creatinine level >141.2 mmol/L (males) or >120.5 mmol/L (females).
- Have an ALT value >53.1 U/L in males, or >39.2 U/L in females.
- Have an AST value >65.0 U/L in males, or >46.5 U/L in females.
- Have a total bilirubin value > 1.4 mg/L
- Have an alkaline phosphatase level > 297.8 U/L in males, or > 255.4 U/L in females.
- Have a white cell count <3.4 x 10(9th)/L or > 8.8 x 10(9th)/L.
- Have a platelet count <97.0 x 10(9th)/L in males, or <118.0 x 10(9th)/L in females
- Have the presence of any glucose or greater than trace amounts of protein in the urine. Have the presence of greater than trace amounts of RBC in the urine of males and non-menstruating females.
- Plan to have surgery between enrollment and the last immunization.
- Have any known allergic reactions or hypersensitivity to any vaccinations in the past.
- Decision to participate in another investigational vaccine/drug research during the period of this study.
- Have any immunizations planned within three weeks of one of the study immunizations.
- Receipt of immunoglobulins or any blood products within three months preceding the initial study immunization or planned administration during the study period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Naval Medical Research Center
Silver Spring, Maryland, 20910-7500
About this study
Official title: A Phase I Trial of PFCSP DNA/MVA.CSO Prime/Boost Vaccine in Mampong, Ghana
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2 doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA) given as a "booster." Forty-eight adults in Ghana, ages 18-50 years, will participate for 17 months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a rabies vaccine at months 0 and 1, and an injection containing no vaccine at month 7. Group 3 will receive the DNA malaria vaccine at months 5 and 6, and the booster at month 7. Group 4 will receive the rabies vaccine at months 5 and 6, and an injection containing no vaccine at month 7. Blood samples and information regarding health problems that may occur after vaccination will be collected.
Read the detailed description
The purpose of this study is to assess the safety, tolerability, and immunogenicity of immunization with 2 doses of the PfCSP DNA vaccine (given 1 month apart) followed by a single dose of MVA.CSO (given either 1 month or 6 months later) when administered to healthy, malaria semi-immune adult volunteers. This Phase 1, randomized study conducted at Tetteh Quarshie Memorial Hospital will enroll 48 healthy volunteers, ages 18 to 50 years. Twenty four volunteers will initially be recruited and randomized to Groups 1 and 2. During Months 4 and 5 of the study, another 24 volunteers will be recruited and randomized to Groups 3 and 4. Group 1 will receive the DNA malaria vaccine intramuscularly (IM) at months 0 and 1, and the MVA malaria vaccine intradermally (ID) at month 7. Group 2 will receive a rabies vaccine IM at months 0 and 1, and a normal saline injection ID at month 7. Group 3 will receive the DNA malaria vaccine IM at months 5 and 6, and the MVA malaria vaccine ID at month 7. Group 4 will receive the rabies vaccine IM at months 5 and 6, and a normal saline injection ID at month 7. Blood samples will be collected at intervals for safety and immunogenicity studies. Vaccine safety will be monitored until 10 months after the final dose. At the conclusion of the study, volunteers randomized to Groups 1 and 3 will have the option of receiving the rabies vaccine. The primary study objectives are to: (1) assess the safety and tolerability of immunization with two doses of PfCSP DNA followed by one dose of MVA.CSO in healthy, malaria semi-immune adult volunteers when given at intervals of 0, 1, and 2 months or at 0, 1, and 7 months; (2) evaluate whether the PfCSP DNA/MVA.CSO prime/boost vaccine regimen induces PfCSP-specific immune responses, as assessed by IFN-gamma ELISPOT assay, over background responses; and (3) evaluate whether extending the interval between the second dose of PfCSP DNA and MVA.CSO from 1 month to 6 months is associated with higher levels of PfCSP specific T cell responses in semi-immune adults. The secondary study objective is to evaluate whether extending the interval between the second dose of PfCSP DNA and MVA.CSO from 1 month to 6 months is associated with higher levels of humoral immunity by ELISA and IFAT in semi-immune adults. The principal outcome measure will be the incidence of any vaccine related adverse event, abnormal lab values, and local or systemic reactions. An additional outcome variable for the remaining primary objectives is the results of the IFN-gamma ELISPOT assay at 1 week after administration of MVA.CSO. This study is planned to be the first of multiple clinical trials designed to test malaria vaccines in adults, children, and infants in endemic regions of Ghana.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- MVA-CSO Vaccine, PfCSP DNA (VCL-2510) Vaccine
- Keywords
- malaria, Plasmodium falciparum, vaccine, Ghana
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-CSO VaccineBiological
PfCSP DNA (VCL-2510) VaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377494
- Sponsor's protocol ID
- 04-070
- Other IDs
- NMIMR: CPN 042/03-04
- Status last verified
- Feb 2007
- First submitted
- 14 Sep 2006
- Last updated
- 23 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of PFCSP DNA/MVA.CSO Prime/Boost Vaccine in Mampong, Ghana
- ClinicalTrials.gov ID
- NCT00377494
- Acronym / sponsor ID
- 04-070
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- malaria, Plasmodium falciparum, vaccine, Ghana
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2008
- First posted
- 18 Sep 2006 (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.
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2 doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA) given as a "booster." Forty-eight adults in Ghana, ages 18-50 years, will participate for 17 months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a rabies vaccine at months 0 and 1, and an injection containing no vaccine at month 7. Group 3 will receive the DNA malaria vaccine at months 5 and 6, and the booster at month 7. Group 4 will receive the rabies vaccine at months 5 and 6, and an injection containing no vaccine at month 7. Blood samples and information regarding health problems that may occur after vaccination will be collected.
Detailed description
The purpose of this study is to assess the safety, tolerability, and immunogenicity of immunization with 2 doses of the PfCSP DNA vaccine (given 1 month apart) followed by a single dose of MVA.CSO (given either 1 month or 6 months later) when administered to healthy, malaria semi-immune adult volunteers. This Phase 1, randomized study conducted at Tetteh Quarshie Memorial Hospital will enroll 48 healthy volunteers, ages 18 to 50 years. Twenty four volunteers will initially be recruited and randomized to Groups 1 and 2. During Months 4 and 5 of the study, another 24 volunteers will be recruited and randomized to Groups 3 and 4. Group 1 will receive the DNA malaria vaccine intramuscularly (IM) at months 0 and 1, and the MVA malaria vaccine intradermally (ID) at month 7. Group 2 will receive a rabies vaccine IM at months 0 and 1, and a normal saline injection ID at month 7. Group 3 will receive the DNA malaria vaccine IM at months 5 and 6, and the MVA malaria vaccine ID at month 7. Group 4 will receive the rabies vaccine IM at months 5 and 6, and a normal saline injection ID at month 7. Blood samples will be collected at intervals for safety and immunogenicity studies. Vaccine safety will be monitored until 10 months after the final dose. At the conclusion of the study, volunteers randomized to Groups 1 and 3 will have the option of receiving the rabies vaccine. The primary study objectives are to: (1) assess the safety and tolerability of immunization with two doses of PfCSP DNA followed by one dose of MVA.CSO in healthy, malaria semi-immune adult volunteers when given at intervals of 0, 1, and 2 months or at 0, 1, and 7 months; (2) evaluate whether the PfCSP DNA/MVA.CSO prime/boost vaccine regimen induces PfCSP-specific immune responses, as assessed by IFN-gamma ELISPOT assay, over background responses; and (3) evaluate whether extending the interval between the second dose of PfCSP DNA and MVA.CSO from 1 month to 6 months is associated with higher levels of PfCSP specific T cell responses in semi-immune adults. The secondary study objective is to evaluate whether extending the interval between the second dose of PfCSP DNA and MVA.CSO from 1 month to 6 months is associated with higher levels of humoral immunity by ELISA and IFAT in semi-immune adults. The principal outcome measure will be the incidence of any vaccine related adverse event, abnormal lab values, and local or systemic reactions. An additional outcome variable for the remaining primary objectives is the results of the IFN-gamma ELISPOT assay at 1 week after administration of MVA.CSO. This study is planned to be the first of multiple clinical trials designed to test malaria vaccines in adults, children, and infants in endemic regions of Ghana.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults, 18-50 years of age.
- Available to participate for the duration of the study period.
- HIV seronegative, per written proof of assay collected within four weeks of screening
- Provision of personal (not proxy) agreement to consent to the study.
Key exclusion criteria (24 listed)
- Females who are pregnant or nursing, who plan on becoming pregnant or plan to nurse during the study period, or males who plan on fathering children during the study period.
- Have a history of diabetes or any cardiovascular disorder
- Have hypertension, or current treatment with anti-hypertensives.
- Have a total cholesterol >197.5 mg/dL.
- Have an abnormal EKG (e.g., all kinds of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, A-V node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, or 2 premature ventricular contractions (PVC) in a row, or ST elevation consistent with ischemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-CSO Vaccine | Biological | – |
| PfCSP DNA (VCL-2510) Vaccine | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-CSO Vaccine and PfCSP DNA (VCL-2510) Vaccine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
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 24 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: withdrawn, as of the sponsor's last update on 23 Jan 2019. 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, Ghana. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 23 Jan 2019.