MalariaPhase 1NCT03590340
Regimen Optimization Trial of PfSPZ Vaccine in Equatorial Guinea
A Phase 1 study testing PfSPZ Vaccine, Normal saline and PfSPZ Challenge (for CHMI) in people with Malaria, run by Sanaria Inc. at 1 site in Equatorial Guinea.
Trial summary
This is a phase 1, randomized regimen optimization study of PfSPZ Vaccine in healthy Equatoguinean volunteers to determine if a condensed, rapid immunization regimen is safe and efficacious. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- PfSPZ Vaccine, Normal saline and PfSPZ Challenge (for CHMI)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteEquatorial Guinea
- Study dates
- 30 Jul 2018to 12 Mar 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and non-pregnant/non-lactating females, age 18 to 45 years at time of enrollment.
- Provision of signed and dated informed consent form.
- Demonstrate understanding of the study by responding correctly to 10 out of 10 true/false statements about the trial (a maximum of two additional attempts will be granted for those who fail to respond correctly to all true/false statements in their first attempt).
- Stated availability and willingness to comply with all study procedures and visits for the duration of the trial, including the required vaccination and post-CHMI ward observation period.
- Able to understand and communicate in Spanish, the national language of Equatorial Guinea
- Be in good general health as evidenced by medical history, screening physical examination and laboratory findings.
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- Females of child bearing potential must agree to use injectable medroxyprogesterone for at least 4 weeks prior to enrollment and agree to continue to use medroxyprogesterone during the entire study period.
- Female subjects must not be pregnant (as demonstrated by a negative urine pregnancy test) at enrollment and prior to each immunization.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
- At least one year of residence on Bioko Island, Equatorial Guinea, and living close enough to Baney Clinical Research Center and Sampaka Hospital to be able to attend the required appointments at the study center.
- Agree to release medical information and inform a study doctor about contraindications for participation in the study.
- Willingness to be attended to by a study doctor and take all medications prescribed during the study period.
- Agree to provide contact information of a third-party household member or close friend to the study team.
- Agree not to participate in another clinical trial during the study period.
- Agree not to donate blood during the study period.
- Willing to undergo HIV, hepatitis B (HBV) and hepatitis C (HCV) tests.
- Reachable by telephone for adverse event review.
Who cannot join
- Known allergic reactions to components of PfSPZ Vaccine, PfSPZ Challenge, or artemether-lumefantrine (AL).
- Having received an investigational malaria vaccine in the last 5 years.
- Having received any non-live vaccine in the 14 days prior to enrollment, any live vaccine in the 28 days prior to enrollment or three or more of any type of vaccine in the four months prior to enrollment.
- Participation in any other clinical study involving investigational medicinal products including malaria drugs within 30 days prior to enrollment.
- History of arrhythmias, prolonged QT-interval or other cardiac disease, or clinically significant abnormalities on electrocardiogram (ECG) at screening.
- History of non-febrile seizures or complex febrile seizures.
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- History of cardiac disease in a 1st or 2nd degree relative when <50 years of age.
- A chronic illness including diabetes mellitus, cancer, HIV/AIDS, tuberculosis.
- History of illicit drug or alcohol use that interferes with normal social function.
- The use of chronic immunosuppressive drugs or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period.
- Any clinically significant deviation from the normal range in biochemistry, hematology or urinalysis tests.
- Positive HIV, hepatitis B virus or hepatitis C virus serologic tests.
- Signs and symptoms of tuberculosis (e.g., chronic cough, night sweats, chronic fever, enlarged lymph nodes, unintended weight loss), or risk factors in an otherwise healthy person in combination with a positive tuberculin skin test (TST).
- Symptoms, physical signs and/or laboratory values suggestive of systemic disorders including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteer.
- Any medical, psychiatric, social or occupational condition or situation that, in the judgment of the PI, impairs the volunteer's ability to give informed consent, increases the risk to the volunteer of participation in the study, affects the ability of the volunteer to participate fully in the study, or might negatively impact the quality, consistency or interpretation of data derived from their participation in the study.
Trial locations and contacts
1 site in 1 country.
Equatorial Guinea1 site
Baney Clinical Research Center
Santiago de Baney, Bioko Island
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Regimen Optimization Study of a Radiation-Attenuated Plasmodium Falciparum (Pf) Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults
This is a phase 1, randomized regimen optimization study of PfSPZ Vaccine in healthy Equatoguinean volunteers to determine if a condensed, rapid immunization regimen is safe and efficacious. Four different regimens 4 weeks or less in duration will be evaluated for safety, tolerability, immunogenicity, and protective efficacy in comparison to a gold standard 16-week regimen.
Read the detailed description
This double-blind, placebo-controlled clinical trial will be conducted in 104 Equatoguinean healthy men and women 18-45 years of age divided into four groups of 26 subjects receiving one of four dosing regimens. The study is designed to test the hypothesis that 2 or 4 doses of 9x10^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) over 6-7 days as the priming immunization, with or without a boosting immunization at 4 or 16 weeks after the last priming dose, will (1) be safe and well tolerated; and (2) induce immunity leading to protection against homologous controlled human malaria infection (CHMI) performed at 8 weeks after the final immunization by DVI injection of PfSPZ Challenge. The first regimen will test the radiation-attenuated whole sporozoite PfSPZ Vaccine in a dose of 9.0x10^5 administered by DVI with four priming immunizations followed by a boost after 16 weeks. The second regimen will follow the same dosing and administering schedule, but without the boost after 16 weeks to study if a boost may be necessary. The third regimen will follow the first regimen with the interval duration to the boost shortened to only 4 weeks. In the fourth and final regimen, the vaccine will be administered two times instead of four followed by a boost in 4 weeks to evaluate if two priming immunizations will be sufficient to confer protection. In summary:
- Group 1: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive normal saline (NS) placebo on Days 1, 3, 5, 7, and 113.
- Group 2: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1, 3, 5, and 7.
- Group 3: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1, 3, 5, 7, and 29.
- Group 4: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1 and 8.
The safety and tolerability of each regimen will be measured by recording (1) solicited and unsolicited adverse events, (2) immunogenicity by assessing humoral and cellular immune responses pre- and post-vaccination, and (3) vaccine efficacy (VE) by measuring protection against homologous CHMI administered by DVI of PfSPZ Challenge (NF54) at 8 weeks post-final vaccination.
- Conditions
- Malaria
- Being tested
- PfSPZ Vaccine, Normal saline, PfSPZ Challenge (for CHMI)
- Keywords
- Plasmodium falciparum, PfSPZ Vaccine, PfSPZ Challenge (NF54), CHMI
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ VaccineBiological
Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
Normal salineOther
Normal saline is 0.9% sodium chloride
PfSPZ Challenge (for CHMI)Biological
Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54
| Study group | Role | What they receive |
|---|---|---|
| Group 1a (PfSPZ Vaccine) | Experimental | Group 1a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 113.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (for CHMI) |
| Group 2a (PfSPZ Vaccine) | Experimental | Group 2a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last prime dose by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (for CHMI) |
| Group 3a (PfSPZ Vaccine) | Experimental | Group 3a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 29.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (for CHMI) |
| Group 4a (PfSPZ Vaccine) | Experimental | Group 4a: subjects (n=21) will receive two doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1 and 8 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 29.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (for CHMI) |
| Group 1b (NS) | Placebo comparator | Group 1b: subjects (n=5) will receive normal saline (NS) placebo on Days 1, 3, 5, 7, and 113.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. Receives: Other: Normal saline; Biological: PfSPZ Challenge (for CHMI) |
| Group 2b (NS) | Placebo comparator | Group 2b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, and 7.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. Receives: Other: Normal saline; Biological: PfSPZ Challenge (for CHMI) |
| Group 3b (NS) | Placebo comparator | Group 3b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, 7, and 29.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. Receives: Other: Normal saline; Biological: PfSPZ Challenge (for CHMI) |
| Group 4b (NS) | Placebo comparator | Group 4b: subjects (n=5) will receive NS placebo on Days 1 and 8.
CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. Receives: Other: Normal saline; Biological: PfSPZ Challenge (for CHMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of Adverse Events (AEs)
- Occurrence of solicited local AEs during priming vaccination and a 3-day surveillance period after priming and boost vaccinations.
- Occurrence of solicited systemic AEs during priming vaccination and a 7-day surveillance period after priming and boost vaccinations.
- Occurrence of unsolicited AEs during priming vaccination and a 14-day surveillance period after priming and boost vaccinations.
- Occurrence of serious adverse events (SAEs) during the study.
Measured: Day of first immunization until 1 year
Secondary outcomes (3)
Proportion of volunteers who become parasitemic will be recorded, detected by thick blood smear microscopy (TBS) and/ or quantitative real time polymerase chain reaction (qPCR)
- Development of Pf parasitemia by TBS following CHMI
- Development of Pf parasitemia by qPCR following CHM
Measured: Post first immunization uptil 56 days post-CHMI
Level of Antibodies against Pf proteins in volunteer sera
- Antibody titres to pre-erythrocytic stage and erythrocytic stage antigens[PfCSP, PfLSA-1, PfEBA-175 , PfMSP-1, PfMSP-5, EXP-1] by ELISA
- Antibody titres to Pf sporozoites, asexual and sexual erythrocytic stage parasites by IFA.
- Analysis of antibodies to proteins in the Pf proteome array chip.
Measured: Post first immunization uptil 56 days post-CHMI
Inhibitory Capacity of Volunteer Sera against in vitro Sporozoite Invasion of Hepatocytes
Capacity of sera from immunized volunteers to inhibit sporozoite invasion (ISI) of hepatocytes in vitro by ISI assay
Measured: Post first immunization uptil 56 days post-CHMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start30 Jul 2018
- Primary completion12 Mar 2019
- Study completion12 Mar 2019
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 MalariaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ifakara Health Institute, Swiss Tropical & Public Health Institute, Government of Equatorial Guinea, Noble Oil Services, Marathon Oil Corporation, Atlantic Methanol Production Company, Equatorial Guinea (EG) liquefied natural gas (LNG)
- Responsible party
- Sponsor
- Investigators
- Said Jongo, MD, MMed, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590340
- Sponsor's protocol ID
- EGSPZV3
- Status last verified
- Jan 2020
- First submitted
- 12 Jun 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mpina M, Stabler TC, Schindler T, Raso J, Deal A, Acuche Pupu L, Nyakarungu E, Del Carmen Ovono Davis M, Urbano V, Mtoro A, Hamad A, Lopez MSA, Pasialo B, Eyang MAO, Rivas MR, Falla CC, Garcia GA, Momo JC, Chuquiyauri R, Saverino E, Preston Church LW, Kim Lee Sim B, Manguire B, Tanner M, Maas C, Abdulla S, Billingsley PF, Hoffman SL, Jongo S, Richie TL, Daubenberger CA. Diagnostic performance and comparison of ultrasensitive and conventional rapid diagnostic test, thick blood smear and quantitative PCR for detection of low-density Plasmodium falciparum infections during a controlled human malaria infection study in Equatorial Guinea. Malar J. 2022 Mar 24;21(1):99. doi: 10.1186/s12936-022-04103-y.
PubMed 35331251
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Regimen Optimization Study of a Radiation-Attenuated Plasmodium Falciparum (Pf) Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults
- ClinicalTrials.gov ID
- NCT03590340
- Acronym / sponsor ID
- EGSPZV3
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, PfSPZ Vaccine, PfSPZ Challenge (NF54), CHMI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ifakara Health Institute, Swiss Tropical & Public Health Institute, Government of Equatorial Guinea, Noble Oil Services, Marathon Oil Corporation, Atlantic Methanol Production Company, Equatorial Guinea (EG) liquefied natural gas (LNG)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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 is a phase 1, randomized regimen optimization study of PfSPZ Vaccine in healthy Equatoguinean volunteers to determine if a condensed, rapid immunization regimen is safe and efficacious. Four different regimens 4 weeks or less in duration will be evaluated for safety, tolerability, immunogenicity, and protective efficacy in comparison to a gold standard 16-week regimen.
Detailed description
This double-blind, placebo-controlled clinical trial will be conducted in 104 Equatoguinean healthy men and women 18-45 years of age divided into four groups of 26 subjects receiving one of four dosing regimens. The study is designed to test the hypothesis that 2 or 4 doses of 9x10^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) over 6-7 days as the priming immunization, with or without a boosting immunization at 4 or 16 weeks after the last priming dose, will (1) be safe and well tolerated; and (2) induce immunity leading to protection against homologous controlled human malaria infection (CHMI) performed at 8 weeks after the final immunization by DVI injection of PfSPZ Challenge. The first regimen will test the radiation-attenuated whole sporozoite PfSPZ Vaccine in a dose of 9.0x10^5 administered by DVI with four priming immunizations followed by a boost after 16 weeks. The second regimen will follow the same dosing and administering schedule, but without the boost after 16 weeks to study if a boost may be necessary. The third regimen will follow the first regimen with the interval duration to the boost shortened to only 4 weeks. In the fourth and final regimen, the vaccine will be administered two times instead of four followed by a boost in 4 weeks to evaluate if two priming immunizations will be sufficient to confer protection. In summary:
- Group 1: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive normal saline (NS) placebo on Days 1, 3, 5, 7, and 113.
- Group 2: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1, 3, 5, and 7.
- Group 3: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1, 3, 5, 7, and 29.
- Group 4: 21 subjects will receive 9.0x10^5 PfPSZ and 5 subjects will receive NS on Days 1 and 8.
The safety and tolerability of each regimen will be measured by recording (1) solicited and unsolicited adverse events, (2) immunogenicity by assessing humoral and cellular immune responses pre- and post-vaccination, and (3) vaccine efficacy (VE) by measuring protection against homologous CHMI administered by DVI of PfSPZ Challenge (NF54) at 8 weeks post-final vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1a (PfSPZ Vaccine) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (for CHMI)Group 1a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 113. Controlled human malaria infection (CHMI) with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 2a (PfSPZ Vaccine) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (for CHMI)Group 2a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last prime dose by DVI injection. |
| Group 3a (PfSPZ Vaccine) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (for CHMI)Group 3a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 4a (PfSPZ Vaccine) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (for CHMI)Group 4a: subjects (n=21) will receive two doses of PfSPZ Vaccine (9.0 x 10^5 PfSPZ/dose) on Days 1 and 8 as a prime, followed by a boost of 9.0x10^5 PfSPZ Vaccine on Day 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 1b (NS) | Placebo comparator | Other: Normal saline, Biological: PfSPZ Challenge (for CHMI)Group 1b: subjects (n=5) will receive normal saline (NS) placebo on Days 1, 3, 5, 7, and 113. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 2b (NS) | Placebo comparator | Other: Normal saline, Biological: PfSPZ Challenge (for CHMI)Group 2b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, and 7. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 3b (NS) | Placebo comparator | Other: Normal saline, Biological: PfSPZ Challenge (for CHMI)Group 3b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, 7, and 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 4b (NS) | Placebo comparator | Other: Normal saline, Biological: PfSPZ Challenge (for CHMI)Group 4b: subjects (n=5) will receive NS placebo on Days 1 and 8. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy males and non-pregnant/non-lactating females, age 18 to 45 years at time of enrollment.
- Provision of signed and dated informed consent form.
- Demonstrate understanding of the study by responding correctly to 10 out of 10 true/false statements about the trial (a maximum of two additional attempts will be granted for those who fail to respond correctly to all true/false statements in their first attempt).
- Stated availability and willingness to comply with all study procedures and visits for the duration of the trial, including the required vaccination and post-CHMI ward observation period.
- Able to understand and communicate in Spanish, the national language of Equatorial Guinea
Key exclusion criteria (15 listed)
- Known allergic reactions to components of PfSPZ Vaccine, PfSPZ Challenge, or artemether-lumefantrine (AL).
- Having received an investigational malaria vaccine in the last 5 years.
- Having received any non-live vaccine in the 14 days prior to enrollment, any live vaccine in the 28 days prior to enrollment or three or more of any type of vaccine in the four months prior to enrollment.
- Participation in any other clinical study involving investigational medicinal products including malaria drugs within 30 days prior to enrollment.
- History of arrhythmias, prolonged QT-interval or other cardiac disease, or clinically significant abnormalities on electrocardiogram (ECG) at screening.
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 VaccineMetabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine) | Biological | Group 1a (PfSPZ Vaccine), Group 2a (PfSPZ Vaccine), Group 3a (PfSPZ Vaccine), Group 4a (PfSPZ Vaccine) |
| Normal salineNormal saline is 0.9% sodium chloride | Other | Group 1b (NS), Group 2b (NS), Group 3b (NS), Group 4b (NS) |
| PfSPZ Challenge (for CHMI)Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54 | Biological | Group 1a (PfSPZ Vaccine), Group 1b (NS), Group 2a (PfSPZ Vaccine), Group 2b (NS), Group 3a (PfSPZ Vaccine), Group 3b (NS), Group 4a (PfSPZ Vaccine), Group 4b (NS) |
Primary outcome
Incidence and type of Adverse Events (AEs)
Time frame: Day of first immunization until 1 year
1. Occurrence of solicited local AEs during priming vaccination and a 3-day surveillance period after priming and boost vaccinations. 2. Occurrence of solicited systemic AEs during priming vaccination and a 7-day surveillance period after priming and boost vaccinations. 3. Occurrence of unsolicited AEs during priming vaccination and a 14-day surveillance period after priming and boost vaccinations. 4. Occurrence of serious adverse events (SAEs) during the study.
3 secondary outcomes
Proportion of volunteers who become parasitemic will be recorded, detected by thick blood smear microscopy (TBS) and/ or quantitative real time polymerase chain reaction (qPCR)
Time frame: Post first immunization uptil 56 days post-CHMI
Level of Antibodies against Pf proteins in volunteer sera
Time frame: Post first immunization uptil 56 days post-CHMI
Inhibitory Capacity of Volunteer Sera against in vitro Sporozoite Invasion of Hepatocytes
Time frame: Post first immunization uptil 56 days post-CHMI
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 7 Jan 2020.
- Derived from this study: PubMed 35331251Mpina M, Stabler TC, Schindler T, Raso J, Deal A, Acuche Pupu L, Nyakarungu E, Del Carmen Ovono Davis M, Urbano V, Mtoro A, Hamad A, Lopez MSA, Pasialo B, Eyang MAO, Rivas MR, Falla CC, Garcia GA, Momo JC, Chuquiyauri R, Saverino E, Preston Church LW, Kim Lee Sim B, Manguire B, Tanner M, Maas C, Abdulla S, Billingsley PF, Hoffman SL, Jongo S, Richie TL, Daubenberger CA. Diagnostic performance and comparison of ultrasensitive and conventional rapid diagnostic test, thick blood smear and quantitative PCR for detection of low-density Plasmodium falciparum infections during a controlled human malaria infection study in Equatorial Guinea. Malar J. 2022 Mar 24;21(1):99. doi: 10.1186/s12936-022-04103-y.
- Individual participant dataSharing planned: No
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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.
Said Jongo, MD, MMed principal investigator
Ifakara Health Institute
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, Normal saline and PfSPZ Challenge (for CHMI) in people with Malaria, run by Sanaria Inc. at 1 site in Equatorial Guinea.
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 17 inclusion and 15 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 7 Jan 2020. 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 Equatorial Guinea. 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?
Incidence and type of Adverse Events (AEs) (time frame: Day of first immunization until 1 year). 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 NCT03590340, 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 7 Jan 2020.