MalariaPhase 1NCT01988636
Study of Safety and Effectiveness of Intravenous Immunization With PfSPZ Vaccine in Healthy African Adults
A Phase 1 study testing PfSPZ Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Background: Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- PfSPZ Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteMali
- Study dates
- 29 Oct 2013to 20 Aug 2015
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must satisfy all the following criteria to be eligible for the study:
- Signed informed consent form (ICF)
- Aged 18 to 35 years
- Long term resident of study site (living there for at least 4 years)
- Willingness to remain resident in the village and to abstain from travel for prolonged periods during the study
- Willingness to undergo an HIV test and other tests needed for determining exclusion. (In case of a positive test, the clinician will issue a referral letter to the participant to guide him/her to HIV specialist care for appropriate management and follow up).
Show all 10Show fewer
- Willingness to take a curative anti-malarial regimen when prescribed by the investigator
- Willingness to provide blood for safety data.
- For females: agreement to use reliable contraception (in the setting where this trial takes place documented depot injection of contraceptives, surgical sterilization ; or an implanted device (all with written evidence provided by an appropriately trained physician) is considered reliable contraception) for the duration of the vaccination phase (i.e., from 1 month prior to first vaccination until 1 month after last vaccination)
- For females: negative pregnancy test at screening and before each vaccination; women found pregnant will not be given subsequent doses but will be followed up for safety reasons
Who cannot join
- Use of antimalarials (other than that prescribed by the investigator) or systemic antibiotics with known antimalarial activity within 30 days prior to the first vaccine dose (e.g. Trimethoprim-Sulfamethoxazole, Doxycycline, Tetracycline, Clindamycin, Erythromycin, Fluoroquinolones, or Azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- Prior receipt of a malaria vaccine candidate
- Recurrent, severe infections other than malaria, and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
- A history of allergic disease or significant reactions against mosquito bites
Show all 30Show fewer
- Known allergies or contraindications against Artemether/Lumefantrine, or
- Atovaquone/Proguanil, such as:
- Concurrent medication with Neuroleptics, Antidepressants (i.e., Imipramine, Amitryptilline, Clomipramine and others), Drugs used to treat tuberculosis, including Rifampicin and Rifabutine, Macrolide antibiotics (i.e., Erythromycin, Clarithromycin, Azithromycin, Roxitromycin), Fluoroquinolones (i.e., Ciprofloxacin, Moxifloxacin, Levofloxacin), Antimykotics (i.e., Ketoconazole, Itraconazole), Cimetidine, Class IA and class III antiarrhythmics (i.e., Quinidine, Ajmalin, Disopyramid, Amiodaron, Sotalol), Flecainid, Metoprolol, Cisaprid, Terfenadin, Astemizole, and Metoclopramide
- Renal impairment
- Symptoms of low potassium, and/or low magnesium
- A family history of sudden cardiac death, which in the opinion of the investigator was caused by a pre-existing arrhythmia
- Known diagnosis or family history of long QT syndrome
- Heart disease (i.e., heart failure, arrhythmias)
- History of cancer (except basal cell carcinoma)
- History of serious psychiatric condition that may affect participation in the study
- If female: currently pregnant, lactating and / or breast-feeding
- Any other serious chronic illness requiring hospital specialist supervision such as diabetes mellitus type 2.
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g per day
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Any confirmed or suspected immunosuppressive or immune modulating disorder (i.e., asplenia, lupus, rheumatoid arthritis, vasculitis, sclerodermia, diabetes mellitus)
- Hematuria, proteinuria, glucosuria as detected by urine dip stick above the levels defined in Appendix F
- Any clinically significant abnormalities on a 12 lead ECG
- Seropositive for Hepatitis B surface antigen (HBsAg)
- Seropositive for Hepatitis C virus (antibodies to HCV)
- Seropositive for HIV
- Seropositive for Syphilis
- Sickle cell trait carriage or sickle cell disease
- Any clinically significant abnormal finding on biochemistry or hematology blood tests, urinalysis or clinical examination
- Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Immunogenicity of Intravenous Immunization With Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) in Healthy African Adults
Background:
- Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to find a safe vaccine that helps prevent malaria.
Read more
Objectives:
- To see if a new malaria vaccine is well tolerated and effective.
Eligibility:
- Healthy adults 18 35 years old who are not pregnant and live in Mali.
Design:
- Participants will be screened with medical history, physical exam, and blood test. They will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals.
- Study participation will last about 1 year.
- Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses of placebo.
- Doses will be given through a needle in the arm directly into the bloodstream. Then participants must stay at the clinic for 2 hours.
- After each dose, participants will return to the clinic several times for blood tests and physical exam.
- A week before the first dose and 2 weeks after the last, participants will take a full course of anti-malaria drugs.
- If a participant gets malaria during the study, they will take another course of anti-malaria drugs.
Read the detailed description
For decades it is known that humans can be protected against malaria by repeated immunization with radiation-attenuated sporozoites. Traditionally, those sporozoites are administered by exposing the vaccinee to at least 1000 bites of sporozoite-infected irradiated mosquitoes, an approach that is unsuitable for mass vaccination campaigns. Recently, Sanaria Inc. 1 has developed a process for manufacturing, in compliance with current Good Manufacturing Practices (cGMPs) aseptic, purified, radiation attenuated cryopreserved sporozoites from a wellcharacterized isolate of P. falciparum. This product, which is called PfSPZ Vaccine, can be administered by needle and syringe. Previous studies conducted by the Vaccine Research Center, National Institutes of Health (NIH) and the Navy have established that IV administration of PfSPZ Vaccine can induce sterile protection against controlled human malaria infection (CHMI) with a homologous strain of P. falciparum in up to 100% of malaria na(SqrRoot) ve individuals.
The next logical step is to test the safety and immunogenicity of PfSPZ Vaccine in malaria experienced individuals. As an exploratory objective, this study will collect initial data to find out if the vaccine can protect against naturally occurring infection. Here, we propose a randomized double blind controlled trial to assess the safety and immunogenicity of IV administration of PfSPZ Vaccine in African adults.
Subjects will be recruited from a rural village in Mali. The study will be conducted as collaboration among the Malaria Research and Training Center (MRTC, Mali), the Laboratory of Malaria Immunology and Vaccinology (LMIV) National Institute of Allergy and Infectious Diseases (NIAID), and Sanaria, Inc. Group 1 (n=12), will receive 135,000 PfSPZ Vaccine, followed by 270,000 PfSPZ Vaccine 2 weeks later for safety purposes. An independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed with 270,000 PfSPZ Vaccine.
At Study Week 4, Group 4 (n=50) will receive their first of 5 doses of 270,000 PfSPZ Vaccine given at 4, 8, 12, 16, and 24 weeks, alongside Group 5 (n=50) receiving a similar volume placebo. Safety data will be collected at defined time points after each immunization. From Week 28 until Week 48 all subjects will be monitored for parasitemia detected by slide microscopy every 14 days and by passive case detection.
- Conditions
- Malaria
- Being tested
- PfSPZ Vaccine, Placebo
- Keywords
- Randomized, Double Blinded, Mali, Malaria, Transmission
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ VaccineBiological
Aseptic, purified, vialed, cryopreserved, radiation attenuated NF54 p.falciparum sporozoites produced by Sanaria, Inc.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pilot Safety Group- 135000 PfSPZ + 270000 PfSPZ; staggered at Day 0 and 2 weeks Receives: Biological: PfSPZ Vaccine |
| Group 4 | Active comparator | Group to start at week 4 after Group 1 is deemed safe - 5 immunizations of 270000 PfSPZ at weeks 4, 8, 12, 16 and 24 Receives: Biological: PfSPZ Vaccine |
| Group 5 | Placebo comparator | Group to receive placebo at same points as Group 4 - 5 immunizations of normal saline at weeks 4, 8, 12, 16 and 24 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of repeated IV immunizations with PfSPZ Vaccine
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start29 Oct 2013
- Primary completion20 Aug 2015
- Study completion20 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Sanaria Inc.
- Responsible party
- Sponsor
- Investigators
- Sara A Healy, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988636
- Sponsor's protocol ID
- 999914010
- Other IDs
- 14-I-N010
- Status last verified
- 20 Aug 2015
- First submitted
- 9 Nov 2013
- Last updated
- 3 Dec 2019
- Results posted
- No
Publications
Hoffman SL, Billingsley PF, James E, Richman A, Loyevsky M, Li T, Chakravarty S, Gunasekera A, Chattopadhyay R, Li M, Stafford R, Ahumada A, Epstein JE, Sedegah M, Reyes S, Richie TL, Lyke KE, Edelman R, Laurens MB, Plowe CV, Sim BK. Development of a metabolically active, non-replicating sporozoite vaccine to prevent Plasmodium falciparum malaria. Hum Vaccin. 2010 Jan;6(1):97-106. doi: 10.4161/hv.6.1.10396. Epub 2010 Jan 21.
PubMed 19946222Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science. 2013 Sep 20;341(6152):1359-65. doi: 10.1126/science.1241800. Epub 2013 Aug 8.
PubMed 23929949Epstein 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 21903775Sissoko MS, Healy SA, Katile A, Omaswa F, Zaidi I, Gabriel EE, Kamate B, Samake Y, Guindo MA, Dolo A, Niangaly A, Niare K, Zeguime A, Sissoko K, Diallo H, Thera I, Ding K, Fay MP, O'Connell EM, Nutman TB, Wong-Madden S, Murshedkar T, Ruben AJ, Li M, Abebe Y, Manoj A, Gunasekera A, Chakravarty S, Sim BKL, Billingsley PF, James ER, Walther M, Richie TL, Hoffman SL, Doumbo O, Duffy PE. Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial. Lancet Infect Dis. 2017 May;17(5):498-509. doi: 10.1016/S1473-3099(17)30104-4. Epub 2017 Feb 16.
PubMed 28216244
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Immunogenicity of Intravenous Immunization With Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) in Healthy African Adults
- ClinicalTrials.gov ID
- NCT01988636
- Acronym / sponsor ID
- 999914010
- Conditions
- Malaria
- Keywords
- Randomized, Double Blinded, Mali, Malaria, Transmission
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Sanaria Inc.
- Study start
- 29 Oct 2013
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 20 Aug 2015 (actual)
- First posted
- 20 Nov 2013 (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.
Background:
- Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to find a safe vaccine that helps prevent malaria.
Objectives:
- To see if a new malaria vaccine is well tolerated and effective.
Eligibility:
- Healthy adults 18 35 years old who are not pregnant and live in Mali.
Design:
- Participants will be screened with medical history, physical exam, and blood test. They will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals.
- Study participation will last about 1 year.
- Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses of placebo.
- Doses will be given through a needle in the arm directly into the bloodstream. Then participants must stay at the clinic for 2 hours.
- After each dose, participants will return to the clinic several times for blood tests and physical exam.
- A week before the first dose and 2 weeks after the last, participants will take a full course of anti-malaria drugs.
- If a participant gets malaria during the study, they will take another course of anti-malaria drugs.
Detailed description
For decades it is known that humans can be protected against malaria by repeated immunization with radiation-attenuated sporozoites. Traditionally, those sporozoites are administered by exposing the vaccinee to at least 1000 bites of sporozoite-infected irradiated mosquitoes, an approach that is unsuitable for mass vaccination campaigns. Recently, Sanaria Inc. 1 has developed a process for manufacturing, in compliance with current Good Manufacturing Practices (cGMPs) aseptic, purified, radiation attenuated cryopreserved sporozoites from a wellcharacterized isolate of P. falciparum. This product, which is called PfSPZ Vaccine, can be administered by needle and syringe. Previous studies conducted by the Vaccine Research Center, National Institutes of Health (NIH) and the Navy have established that IV administration of PfSPZ Vaccine can induce sterile protection against controlled human malaria infection (CHMI) with a homologous strain of P. falciparum in up to 100% of malaria na(SqrRoot) ve individuals.
The next logical step is to test the safety and immunogenicity of PfSPZ Vaccine in malaria experienced individuals. As an exploratory objective, this study will collect initial data to find out if the vaccine can protect against naturally occurring infection. Here, we propose a randomized double blind controlled trial to assess the safety and immunogenicity of IV administration of PfSPZ Vaccine in African adults.
Subjects will be recruited from a rural village in Mali. The study will be conducted as collaboration among the Malaria Research and Training Center (MRTC, Mali), the Laboratory of Malaria Immunology and Vaccinology (LMIV) National Institute of Allergy and Infectious Diseases (NIAID), and Sanaria, Inc. Group 1 (n=12), will receive 135,000 PfSPZ Vaccine, followed by 270,000 PfSPZ Vaccine 2 weeks later for safety purposes. An independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed with 270,000 PfSPZ Vaccine.
At Study Week 4, Group 4 (n=50) will receive their first of 5 doses of 270,000 PfSPZ Vaccine given at 4, 8, 12, 16, and 24 weeks, alongside Group 5 (n=50) receiving a similar volume placebo. Safety data will be collected at defined time points after each immunization. From Week 28 until Week 48 all subjects will be monitored for parasitemia detected by slide microscopy every 14 days and by passive case detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: PfSPZ VaccinePilot Safety Group- 135000 PfSPZ + 270000 PfSPZ; staggered at Day 0 and 2 weeks |
| Group 4 | Active comparator | Biological: PfSPZ VaccineGroup to start at week 4 after Group 1 is deemed safe - 5 immunizations of 270000 PfSPZ at weeks 4, 8, 12, 16 and 24 |
| Group 5 | Placebo comparator | Drug: PlaceboGroup to receive placebo at same points as Group 4 - 5 immunizations of normal saline at weeks 4, 8, 12, 16 and 24 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent form (ICF)
- Aged 18 to 35 years
- Long term resident of study site (living there for at least 4 years)
- Willingness to remain resident in the village and to abstain from travel for prolonged periods during the study
- Willingness to undergo an HIV test and other tests needed for determining exclusion. (In case of a positive test, the clinician will issue a referral letter to the participant to guide him/her to HIV specialist care for appropriate management and follow up).
Key exclusion criteria (30 listed)
- Use of antimalarials (other than that prescribed by the investigator) or systemic antibiotics with known antimalarial activity within 30 days prior to the first vaccine dose (e.g. Trimethoprim-Sulfamethoxazole, Doxycycline, Tetracycline, Clindamycin, Erythromycin, Fluoroquinolones, or Azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- Prior receipt of a malaria vaccine candidate
- Recurrent, severe infections other than malaria, and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
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 |
|---|---|---|
| PfSPZ VaccineAseptic, purified, vialed, cryopreserved, radiation attenuated NF54 p.falciparum sporozoites produced by Sanaria, Inc. | Biological | Group 1, Group 4 |
| PlaceboPlacebo | Drug | Group 5 |
Primary outcome
Assess the safety of repeated IV immunizations with PfSPZ Vaccine
Time frame: 28 days
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 3 Dec 2019.
- Background: PubMed 19946222Hoffman SL, Billingsley PF, James E, Richman A, Loyevsky M, Li T, Chakravarty S, Gunasekera A, Chattopadhyay R, Li M, Stafford R, Ahumada A, Epstein JE, Sedegah M, Reyes S, Richie TL, Lyke KE, Edelman R, Laurens MB, Plowe CV, Sim BK. Development of a metabolically active, non-replicating sporozoite vaccine to prevent Plasmodium falciparum malaria. Hum Vaccin. 2010 Jan;6(1):97-106. doi: 10.4161/hv.6.1.10396. Epub 2010 Jan 21.
- Background: PubMed 23929949Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science. 2013 Sep 20;341(6152):1359-65. doi: 10.1126/science.1241800. Epub 2013 Aug 8.
- Background: 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.
- Derived from this study: PubMed 28216244Sissoko MS, Healy SA, Katile A, Omaswa F, Zaidi I, Gabriel EE, Kamate B, Samake Y, Guindo MA, Dolo A, Niangaly A, Niare K, Zeguime A, Sissoko K, Diallo H, Thera I, Ding K, Fay MP, O'Connell EM, Nutman TB, Wong-Madden S, Murshedkar T, Ruben AJ, Li M, Abebe Y, Manoj A, Gunasekera A, Chakravarty S, Sim BKL, Billingsley PF, James ER, Walther M, Richie TL, Hoffman SL, Doumbo O, Duffy PE. Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial. Lancet Infect Dis. 2017 May;17(5):498-509. doi: 10.1016/S1473-3099(17)30104-4. Epub 2017 Feb 16.
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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.
Sara A Healy, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PfSPZ Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 10 inclusion and 30 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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. Some participants in this study may receive a placebo. 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?
Assess the safety of repeated IV immunizations with PfSPZ Vaccine (time frame: 28 days). 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 NCT01988636, which also lists 4 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 3 Dec 2019.