MalariaPhase 1NCT00427167
Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine
A Phase 1 study testing AMA1-C1/Alhydrogel + CPG 7909 (Saline), AMA1-C1/Alhydrogel + CPG 7909 (Phosphate) and AMA1-C1/Alhydrogel + CPG 7909 in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- AMA1-C1/Alhydrogel + CPG 7909 (Saline), AMA1-C1/Alhydrogel + CPG 7909 (Phosphate) and AMA1-C1/Alhydrogel + CPG 7909
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2007to 5 Nov 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
- Age between 18 and 50 years, inclusive.
- Good general health as determined by review of medical history and/or clinical tests at screening.
- Available for the duration of the trial (30 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Who cannot join
- Pregnancy as determined by a positive urine beta-hCG at any time during the study (if female).
- Participant unwilling to use reliable contraception methods for at least 2 weeks prior to vaccination and for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
- Currently breast-feeding (if female).
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- Neutropenia as defined by an absolute neutrophil count less than 1500/mm(3).
- Alanine aminotransaminase (ALT) level above the laboratory-defined upper limit of normal.
Show all 28Show fewer
- Serum creatinine level above the laboratory-defined upper limit of normal.
- Hemoglobin below the laboratory-defined lower limit of normal, by sex.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
- History of receiving any investigational product within the past 30 days.
- Participant has had medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Positive ELISA and confirmatory Western blot tests for HIV-1.
- Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV).
- Positive hepatitis B surface antigen (HBsAg) by ELISA.
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
- Known immunodeficiency syndrome.
- Positive serum anti-dsDNA titer.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- Receipt of antimalarial prophylaxis during the past 12 months, or receipt of chloroquine or related compounds (amodiaquine or primaquine) in the previous 8 weeks prior to study entry.
- Prior malaria infection.
- Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives.
- History of a known allergy to nickel.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Johns Hopkins University Bloomberg School of Public Health
Washington D.C., District of Columbia, 20037
About this study
Official title: Phase I Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. Each year, about 1 million people are killed by malaria worldwide, most of them young children in Africa. AMA1 C1 may help block the malaria parasite from getting into red blood cells. The vaccine is mixed with Alhydrogel® (Registered Trademark), a material that is commonly added to vaccines to make them work better (also called an adjuvant). Besides evaluating the vaccine, this study will also test two solutions of an experimental adjuvant, CPG 7909-P and CPG 7909-S.
Healthy people between 18 and 50 years of age may be eligible for this 7-month study. Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as shown:
Read more
- Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28 (1-month interval)
- Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28 (1-month interval)
- Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56 (2-month interval)
- Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56 (2-month interval)
Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7.
In addition to the vaccinations, the study includes the following procedures:
- Photographs of the subject's arm where the vaccination is given if a rash develops.
- Daily temperature and symptoms record for the first 6 days after each of the 2 vaccinations, and at any other time there is concern about fever or other symptoms.
- Blood draws about 12 times during the study to check for safety and to measure the antibody response and the effect of the study vaccine.
Some participants may be asked to undergo plasmapheresis, a procedure for collecting plasma, the liquid part of the blood. This is done by using a machine called a blood cell separator. Blood is collected through a needle place...
Read the detailed description
AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The objectives of this Phase 1 study are to confirm the previously demonstrated safety and immunogenicity of AMA1-C1 + CPG 7909 formulated in a phosphate buffer. In addition, this study will evaluate the safety and immunogenicity of AMA1-C1 + CPG 7909 formulated in a saline buffer, and determine if the addition of CPG 7909 in a saline buffer enhances the immune response to AMA1-C1 in a manner similar to that seen with the addition of CPG 7909 in a phosphate buffer. The immunological effect of giving a second dose of vaccine at 1 or 2 months will also be evaluated. The study is a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 24 participants will be enrolled and randomly assigned to 1 of 4 groups in a 2x2 design: 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (phosphate) at a 1-month dosing interval; 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (saline) at a 1 month dosing interval; 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (phosphate) at a 2-month dosing interval; and 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (saline) at a 2 month dosing interval. Safety outcome measures are local and systemic (including laboratory) adverse events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay (ELISA) and parasite growth inhibition assay (GIA), and will be compared among groups.
- Conditions
- Malaria
- Being tested
- AMA1-C1/Alhydrogel + CPG 7909 (Saline), AMA1-C1/Alhydrogel + CPG 7909 (Phosphate), AMA1-C1/Alhydrogel + CPG 7909
- Keywords
- Blood Stage, Investigational, Vaccine, Malaria, Healthy Volunteer, HV
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA1-C1/Alhydrogel + CPG 7909 (Saline)Biological
AMA1-C1/Alhydrogel + CPG 7909 (Phosphate)Biological
AMA1-C1/Alhydrogel + CPG 7909Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and reactogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine in phosphate and saline buffers; and determine the frequency of summarized systemic and local AFs by severity and relationship to the vaccine.
Secondary outcomes (1)
Demonstrate that the immune responses to AMA1-C1 7909 in a saline buffer are not inferior to the immune responses to AMA-C1 + CPG 7909 in a phosphate buffer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study start23 Jan 2007
- Primary completion5 Nov 2008
- Study completion5 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427167
- Sponsor's protocol ID
- 070083
- Other IDs
- 07-I-0083
- Status last verified
- 3 Aug 2009
- First submitted
- 25 Jan 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Narum DL, Thomas AW. Differential localization of full-length and processed forms of PF83/AMA-1 an apical membrane antigen of Plasmodium falciparum merozoites. Mol Biochem Parasitol. 1994 Sep;67(1):59-68. doi: 10.1016/0166-6851(94)90096-5.
PubMed 7838184Crewther PE, Culvenor JG, Silva A, Cooper JA, Anders RF. Plasmodium falciparum: two antigens of similar size are located in different compartments of the rhoptry. Exp Parasitol. 1990 Feb;70(2):193-206. doi: 10.1016/0014-4894(90)90100-q.
PubMed 2404781Waters AP, Thomas AW, Deans JA, Mitchell GH, Hudson DE, Miller LH, McCutchan TF, Cohen S. A merozoite receptor protein from Plasmodium knowlesi is highly conserved and distributed throughout Plasmodium. J Biol Chem. 1990 Oct 15;265(29):17974-9.
PubMed 2211675
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
- Phase I Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00427167
- Acronym / sponsor ID
- 070083
- Conditions
- Malaria
- Keywords
- Blood Stage, Investigational, Vaccine, Malaria, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Jan 2007
- Primary completion
- 5 Nov 2008 (actual)
- Study completion
- 5 Nov 2008 (actual)
- First posted
- 26 Jan 2007 (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 study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. Each year, about 1 million people are killed by malaria worldwide, most of them young children in Africa. AMA1 C1 may help block the malaria parasite from getting into red blood cells. The vaccine is mixed with Alhydrogel® (Registered Trademark), a material that is commonly added to vaccines to make them work better (also called an adjuvant). Besides evaluating the vaccine, this study will also test two solutions of an experimental adjuvant, CPG 7909-P and CPG 7909-S.
Healthy people between 18 and 50 years of age may be eligible for this 7-month study. Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as shown:
- Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28 (1-month interval)
- Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28 (1-month interval)
- Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56 (2-month interval)
- Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56 (2-month interval)
Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7.
In addition to the vaccinations, the study includes the following procedures:
- Photographs of the subject's arm where the vaccination is given if a rash develops.
- Daily temperature and symptoms record for the first 6 days after each of the 2 vaccinations, and at any other time there is concern about fever or other symptoms.
- Blood draws about 12 times during the study to check for safety and to measure the antibody response and the effect of the study vaccine.
Some participants may be asked to undergo plasmapheresis, a procedure for collecting plasma, the liquid part of the blood. This is done by using a machine called a blood cell separator. Blood is collected through a needle place...
Detailed description
AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The objectives of this Phase 1 study are to confirm the previously demonstrated safety and immunogenicity of AMA1-C1 + CPG 7909 formulated in a phosphate buffer. In addition, this study will evaluate the safety and immunogenicity of AMA1-C1 + CPG 7909 formulated in a saline buffer, and determine if the addition of CPG 7909 in a saline buffer enhances the immune response to AMA1-C1 in a manner similar to that seen with the addition of CPG 7909 in a phosphate buffer. The immunological effect of giving a second dose of vaccine at 1 or 2 months will also be evaluated. The study is a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 24 participants will be enrolled and randomly assigned to 1 of 4 groups in a 2x2 design: 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (phosphate) at a 1-month dosing interval; 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (saline) at a 1 month dosing interval; 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (phosphate) at a 2-month dosing interval; and 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1/Alhydrogel + 500 micrograms CPG 7909 (saline) at a 2 month dosing interval. Safety outcome measures are local and systemic (including laboratory) adverse events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay (ELISA) and parasite growth inhibition assay (GIA), and will be compared among groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 50 years, inclusive.
- Good general health as determined by review of medical history and/or clinical tests at screening.
- Available for the duration of the trial (30 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (28 listed)
- Pregnancy as determined by a positive urine beta-hCG at any time during the study (if female).
- Participant unwilling to use reliable contraception methods for at least 2 weeks prior to vaccination and for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
- Currently breast-feeding (if female).
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- Neutropenia as defined by an absolute neutrophil count less than 1500/mm(3).
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 |
|---|---|---|
| AMA1-C1/Alhydrogel + CPG 7909 (Saline) | Biological | – |
| AMA1-C1/Alhydrogel + CPG 7909 (Phosphate) | Biological | – |
| AMA1-C1/Alhydrogel + CPG 7909 | Drug | – |
Primary outcome
Assessment of the safety and reactogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine in phosphate and saline buffers; and determine the frequency of summarized systemic and local AFs by severity and relationship to the vaccine.
1 secondary outcome
Demonstrate that the immune responses to AMA1-C1 7909 in a saline buffer are not inferior to the immune responses to AMA-C1 + CPG 7909 in a phosphate buffer.
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 7838184Narum DL, Thomas AW. Differential localization of full-length and processed forms of PF83/AMA-1 an apical membrane antigen of Plasmodium falciparum merozoites. Mol Biochem Parasitol. 1994 Sep;67(1):59-68. doi: 10.1016/0166-6851(94)90096-5.
- Background: PubMed 2404781Crewther PE, Culvenor JG, Silva A, Cooper JA, Anders RF. Plasmodium falciparum: two antigens of similar size are located in different compartments of the rhoptry. Exp Parasitol. 1990 Feb;70(2):193-206. doi: 10.1016/0014-4894(90)90100-q.
- Background: PubMed 2211675Waters AP, Thomas AW, Deans JA, Mitchell GH, Hudson DE, Miller LH, McCutchan TF, Cohen S. A merozoite receptor protein from Plasmodium knowlesi is highly conserved and distributed throughout Plasmodium. J Biol Chem. 1990 Oct 15;265(29):17974-9.
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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?
A Phase 1 study testing AMA1-C1/Alhydrogel + CPG 7909 (Saline), AMA1-C1/Alhydrogel + CPG 7909 (Phosphate) and AMA1-C1/Alhydrogel + CPG 7909 in people with Malaria, 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 28 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.
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 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.
What does the primary outcome measure?
Assessment of the safety and reactogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine in phosphate and saline buffers; and determine the frequency of summarized systemic and local AFs by severity and relationship to the vaccine.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427167, which also lists 3 linked publications.
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.