Plasmodium FalciparumPhase 1NCT01001650
Clinical Trial of the PfSPZ Vaccine
A Phase 1 study testing Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) in people with Plasmodium Falciparum, run by Sanaria Inc. at 2 sites in United States.
Trial summary
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. 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
- What is being tested?
- Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Sep 2010
- 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 (male or non-pregnant female) 18-50 years of age, inclusive.
- Able and willing to participate for the duration of the study.
- Able and willing to provide written (not proxy) informed consent.
- Women of childbearing potential must agree to use effective means of birth control through the duration of the study.
- Willing to refrain from blood donation (except as required in this study) for 3 years following P. falciparum challenge.
- Agree not to travel to a malaria endemic region during the entire course of the trial.
Who cannot join
- Any history of malaria infection, or travel to a malaria endemic region within 6 months prior to first immunization.
- History of long term residence (>5 years) in area known to have significant transmission of P. falciparum.
- Positive HIV, HBsAg or HCV serology. Positive sickle cell screening test.
- Has evidence of increased cardiovascular disease risk (defined as > 10%, 5 year risk) as determined by the method of Gaziano (Gaziano 2008). Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm2), reported diabetes status, and blood pressure.
- Current use of systemic immunosuppressant pharmacotherapy.
- An abnormal EKG, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block.
Show all 17Show fewer
- Current significant medical condition (cardiovascular, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination.
- History of a splenectomy.
- History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the volunteer's participation in the protocol or compromise the scientific objectives. This may include psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult.
- Plan for surgery between enrollment and challenge.
- Females who are pregnant or nursing, females who plan on becoming pregnant or plan to nurse during the study period.
- Known allergy to any component of the vaccine formulation, history of anaphylactic response to mosquito bites, retinal or visual field changes, or known allergy to the anti-malarial chloroquine phosphate, which will be used to treat volunteers developing malaria after P. falciparum challenge.
- Participation in any study involving another investigational vaccine or drug within 90 days prior to the screening visit, or plan to participate in another investigational vaccine/drug research during or within 1 month following participation in this study.
- Personal beliefs that prohibit the receiving of vaccine product containing human serum albumin within the diluent.
- Use or planned use of any drug with anti-malarial activity that would coincide with immunization or challenge.
- History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine.
- Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone- proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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
About this study
Official title: A Phase 1/2a Trial of the PfSPZ Vaccine Administered Subcutaneously or Intradermally to Malaria-Naïve Adult Volunteers
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:
Read more
- 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.
Read the detailed description
The first clinical trial of the Pf SPZ vaccine is a Phase 1 trial in non-immune healthy adult volunteers. Sanaria is the Sponsor and PATH MVI is funding the trial. The study will be conducted as a collaborative effort between Sanaria, PATH MVI, the NMRC Malaria Program (U.S. Military Malaria Vaccine Program), and the Center for Vaccine Development at the University of Maryland at Baltimore (CVD-UMB). The study will take place at the NMRC Malaria Program Clinical Trials Center on the campus of the National Naval Medical Center in Bethesda, MD and at the CVD and/or General Clinical Research Center, UMB. The study is designed to evaluate the safety, tolerability, immunogenicity and protective efficacy of successively higher doses of the vaccine administered by the subcutaneous (SC) or intradermal (ID) route.
There will be 4 groups of volunteers with each group comprised of a subset of volunteers who receive the vaccine by the SC route and a subset who receive the vaccine by the ID route.
Groups 1-3: The first 3 groups will receive 3 ascending doses of vaccine administered as 4 SC or ID injections separated by 4 week intervals (7,500 PfSPZ/dose, 30,000 PfSPZ/dose, and 135,000 PfSPZ/dose respectively). Each of these groups will be challenged a minimum of 3 weeks after the final dose by exposure to A. stephensi mosquitoes infected with P. falciparum sporozoites. All 3 groups will be followed for safety until 48 weeks after the first immunization.
Group 4: Group 4 will start a minimum of 3 weeks after the first immunization of Group 3. If there is > 80% efficacy in one or more of the subsets of Groups 1, 2, or 3 (SC or ID), Group 4 volunteers will receive 4 immunizations (just like Group 3) but will not have experimental challenge; they will simply be followed for safety for 12 months after the first immunization. The FDA has requested that we follow a group of volunteers receiving the highest dose (135 PfSPZ/immunization) without challenge at 3 weeks. However, if there is NOT > 80% efficacy in one of more subsets of Groups 1, 2, or 3, after a 6 month observation period, Group 4 volunteers will receive two additional monthly immunizations (Immunizations #5 and #6) followed by challenge at approximately 3 weeks after the sixth immunization. All volunteers in Group 4 will be followed for safety until 52 weeks after the first immunization.
- Conditions
- Plasmodium Falciparum
- Being tested
- Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)
- Keywords
- Malaria Vaccine, Plasmodium falciparum
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)Biological
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, and
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 4 doses of 7,500 PfSPZ/immunization. Receives: Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) |
| Group 2 | Experimental | 4 doses of 30,000 PfSPZ/immunization Receives: Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) |
| Group 3 | Experimental | 4 doses of 135,000 PfSPZ/immunization Receives: Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) |
| Group 4 | Experimental | 4 or 6 doses of 135,000 PfSPZ/immunization. Receives: Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: October 2010
Secondary outcomes (2)
To evaluate PfSPZ vaccine-mediated protection against P. falciparum challenge in the 4 groups.
Measured: October 2010
To compare protective efficacy of the PfSPZ vaccine when given by SC versus ID administration in all groups.
Measured: October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionSep 2010
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 Plasmodium FalciparumStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Responsible party
- Sponsor
- Investigators
- Judith E Epstein, M.D., Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001650
- Sponsor's protocol ID
- Sanaria.2008.001
- Other IDs
- NMRC.2008.0004, NNMC: 2008.0071, CVD-UMB Site: H-30076, Malaria CVD 18000, WRAIR DHSP: #1487, HRPO: A-14947, PATH MVI: #PfSPZ001
- Status last verified
- Sep 2014
- First submitted
- 22 Oct 2009
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Epstein JE, Tewari K, Lyke KE, Sim BK, Billingsley PF, Laurens MB, Gunasekera A, Chakravarty S, James ER, Sedegah M, Richman A, Velmurugan S, Reyes S, Li M, Tucker K, Ahumada A, Ruben AJ, Li T, Stafford R, Eappen AG, Tamminga C, Bennett JW, Ockenhouse CF, Murphy JR, Komisar J, Thomas N, Loyevsky M, Birkett A, Plowe CV, Loucq C, Edelman R, Richie TL, Seder RA, Hoffman SL. Live attenuated malaria vaccine designed to protect through hepatic CD8(+) T cell immunity. Science. 2011 Oct 28;334(6055):475-80. doi: 10.1126/science.1211548. Epub 2011 Sep 8.
PubMed 21903775
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Trial of the PfSPZ Vaccine Administered Subcutaneously or Intradermally to Malaria-Naïve Adult Volunteers
- ClinicalTrials.gov ID
- NCT01001650
- Acronym / sponsor ID
- Sanaria.2008.001
- Conditions
- Plasmodium Falciparum
- Keywords
- Malaria Vaccine, Plasmodium falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Oct 2009 (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 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.
Detailed description
The first clinical trial of the Pf SPZ vaccine is a Phase 1 trial in non-immune healthy adult volunteers. Sanaria is the Sponsor and PATH MVI is funding the trial. The study will be conducted as a collaborative effort between Sanaria, PATH MVI, the NMRC Malaria Program (U.S. Military Malaria Vaccine Program), and the Center for Vaccine Development at the University of Maryland at Baltimore (CVD-UMB). The study will take place at the NMRC Malaria Program Clinical Trials Center on the campus of the National Naval Medical Center in Bethesda, MD and at the CVD and/or General Clinical Research Center, UMB. The study is designed to evaluate the safety, tolerability, immunogenicity and protective efficacy of successively higher doses of the vaccine administered by the subcutaneous (SC) or intradermal (ID) route.
There will be 4 groups of volunteers with each group comprised of a subset of volunteers who receive the vaccine by the SC route and a subset who receive the vaccine by the ID route.
Groups 1-3: The first 3 groups will receive 3 ascending doses of vaccine administered as 4 SC or ID injections separated by 4 week intervals (7,500 PfSPZ/dose, 30,000 PfSPZ/dose, and 135,000 PfSPZ/dose respectively). Each of these groups will be challenged a minimum of 3 weeks after the final dose by exposure to A. stephensi mosquitoes infected with P. falciparum sporozoites. All 3 groups will be followed for safety until 48 weeks after the first immunization.
Group 4: Group 4 will start a minimum of 3 weeks after the first immunization of Group 3. If there is > 80% efficacy in one or more of the subsets of Groups 1, 2, or 3 (SC or ID), Group 4 volunteers will receive 4 immunizations (just like Group 3) but will not have experimental challenge; they will simply be followed for safety for 12 months after the first immunization. The FDA has requested that we follow a group of volunteers receiving the highest dose (135 PfSPZ/immunization) without challenge at 3 weeks. However, if there is NOT > 80% efficacy in one of more subsets of Groups 1, 2, or 3, after a 6 month observation period, Group 4 volunteers will receive two additional monthly immunizations (Immunizations #5 and #6) followed by challenge at approximately 3 weeks after the sixth immunization. All volunteers in Group 4 will be followed for safety until 52 weeks after the first immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)4 doses of 7,500 PfSPZ/immunization. |
| Group 2 | Experimental | Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)4 doses of 30,000 PfSPZ/immunization |
| Group 3 | Experimental | Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)4 doses of 135,000 PfSPZ/immunization |
| Group 4 | Experimental | Biological: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)4 or 6 doses of 135,000 PfSPZ/immunization. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults (male or non-pregnant female) 18-50 years of age, inclusive.
- Able and willing to participate for the duration of the study.
- Able and willing to provide written (not proxy) informed consent.
- Women of childbearing potential must agree to use effective means of birth control through the duration of the study.
- Willing to refrain from blood donation (except as required in this study) for 3 years following P. falciparum challenge.
Key exclusion criteria (17 listed)
- Any history of malaria infection, or travel to a malaria endemic region within 6 months prior to first immunization.
- History of long term residence (>5 years) in area known to have significant transmission of P. falciparum.
- Positive HIV, HBsAg or HCV serology. Positive sickle cell screening test.
- Has evidence of increased cardiovascular disease risk (defined as > 10%, 5 year risk) as determined by the method of Gaziano (Gaziano 2008). Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm2), reported diabetes status, and blood pressure.
- Current use of systemic immunosuppressant pharmacotherapy.
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 |
|---|---|---|
| Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)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, and 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. | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
Time frame: October 2010
2 secondary outcomes
To evaluate PfSPZ vaccine-mediated protection against P. falciparum challenge in the 4 groups.
Time frame: October 2010
To compare protective efficacy of the PfSPZ vaccine when given by SC versus ID administration in all groups.
Time frame: October 2010
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 10 Sep 2014.
- Results publication: PubMed 21903775Epstein JE, Tewari K, Lyke KE, Sim BK, Billingsley PF, Laurens MB, Gunasekera A, Chakravarty S, James ER, Sedegah M, Richman A, Velmurugan S, Reyes S, Li M, Tucker K, Ahumada A, Ruben AJ, Li T, Stafford R, Eappen AG, Tamminga C, Bennett JW, Ockenhouse CF, Murphy JR, Komisar J, Thomas N, Loyevsky M, Birkett A, Plowe CV, Loucq C, Edelman R, Richie TL, Seder RA, Hoffman SL. Live attenuated malaria vaccine designed to protect through hepatic CD8(+) T cell immunity. Science. 2011 Oct 28;334(6055):475-80. doi: 10.1126/science.1211548. Epub 2011 Sep 8.
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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.
Judith E Epstein, M.D. principal investigator
Naval Medical Research Center
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 Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) in people with Plasmodium Falciparum, run by Sanaria Inc. 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 6 inclusion and 17 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 10 Sep 2014. 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?
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. (time frame: October 2010). 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 NCT01001650, 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 10 Sep 2014.