Malaria VaccinePhase 2RTSSNCT02992119
Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults
A Phase 2 study testing RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose and RTS,S/AS01E Standard dose in people with Malaria Vaccine, run by University of Oxford at 1 site in Thailand.
Trial summary
Targeted malaria elimination (TME), which comprises appropriate case management by village health workers, vector control and mass drug administration, is currently being implemented through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the scale-up of the intervention to the regional… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Vaccine
- What is being tested?
- RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose and RTS,S/AS01E Standard dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteThailand
- Study dates
- 4 Jun 2017to 20 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is a healthy male or non-pregnant female, aged 18 to 55 years (inclusive), of Thai origin.
- Participant is willing and able to give informed consent to participate in the trial
- Able, in the investigators opinion, and willing to comply with the study requirements and follow-up.
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition).
- Hepatitis B surface antigen (HBsAg) detected in serum.
- Screening ECG demonstrates a QTc interval ≥ 450 ms
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
- Anaemia (Hb < 10 g/dL)
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- Positive malaria parasitaemia at screening or baseline (Month 0, Day 0).
- Use of any investigational or non-registered product or investigational use of a registered product (drug or vaccine), other than the study vaccines, during the period from the date of screening to the first vaccination, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
- Any medical condition that in the judgment of the investigator would make the administration of the antimalarial treatment unsafe, such as prior allergic reactions to one or more component of the drug regimen: artemisinins, piperaquine or primaquine.
- Contraindications to the use of artemisinins, piperaquine or primaquine or use of medications known to have a potentially clinically significant interaction with these medications.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone > 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- History of splenectomy.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection or based on medical history and physical examination.
- History of anaphylaxis post-vaccination.
- Serious chronic illness.
- Any abnormal baseline laboratory screening tests: ALT, AST, creatinine, haemoglobin, platelet count, total WBC, out of normal range as defined in the protocol.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Personal history of autoimmune disease.
- Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Hospital of Tropical Diseases, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
Official title: Safety and Immunogenicity Evaluation of the Malaria Vaccine, RTS,S/AS01, in Healthy Thai Adults
Targeted malaria elimination (TME), which comprises appropriate case management by village health workers, vector control and mass drug administration, is currently being implemented through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the scale-up of the intervention to the regional level are underway. Based on mathematical modelling, extending the post-TME parasitaemia-free period in the majority of villagers for as short as 200 days will substantially increase the chances of achieving the interruption of malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short term malaria protective effect is stronger than the overall effect assessed over 1-2 years. Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed additional protection.
Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian populations. This trial will generate the required data for the use of this vaccine in Asian populations. For integration with the current TME activities, which provide mass drug administrations at months M0, M1, and M2, it would be most efficient and practical to provide the vaccine at the same intervals. To address a two round intervention (M0, M2) where a three round intervention is not feasible, one study arm will look at the immune response generated by only two doses of vaccine and antimalarial medications. Recent evidence suggests that a vaccination schedule which includes a fractional dose of RTS,S/AS01 (1/5th of the standard dose) could be similarly or more protective than a schedule with three standard full doses, while requiring less vaccine and resources. The trial therefore includes study arms which will assess the safety and immunogenicity of fractional dose schedules.
Read more
Each participant will be randomized into one of the following study arms in a ratio of 20:20:30:30:30:30:30, as follows:
- RTS,S/AS01B Fractional dose group (Group 1)
- Double RTS,S /AS01E Fractional dose group (Group 2)
- RTS,S/AS01E Standard dose group (Group 3)
- RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4)
- RTS,S/AS01E Fractional dose group (Group 5)
- RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6)
- RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)
Read the detailed description
This is a randomized, open-label, single centre, Phase 2 trial of RTS,S/AS01 in healthy Thai adults.
Screening and eligibility assessment (Screening visit)
All potential volunteers will have a screening visit, which may take place up to 30 days prior to enrolment. Once informed consent is given, a screening number will be assigned in sequential order. Screening numbers will be issued consecutively (e.g. A-01, A-02, A-03…).
Enrolment, baseline assessment, regimen allocation, and first vaccination (Month 0 / Day 0 visit; Baseline visit) All inclusion and exclusion criteria will be checked before enrolment in the study. Physical examination will be performed. Any new medical issues or symptoms that have arisen will be assessed. Blood will be collected for baseline parasite microscopy, haemoglobin and biochemistry. Participants with parasitaemia or anaemia will be treated according to national guidelines. Blood will be collected and stored for measurement of antibodies against P. falciparum circumsporozoite (anti-CS antibody) until shipment to the reference laboratory. Urine will be collected from women of child-bearing age for immediate pregnancy test.
If all inclusion criteria are fulfilled and none of the exclusion criteria apply, the patient will be enrolled into the study and a CRF specific to each participant completed. Regimen allocation and administration of the vaccine(s) will be on Day 0. The randomization lists will be prepared by MORU.
Randomization numbers will be generated in blocks, for the 7 intervention arms in a ratio of 20:20:30:30:30:30:30, as follows:
Each participant will be randomized into one of the following study arms Group 1: RTS,S/AS01B Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01B full dose Month 2 will receive RTS,S/AS01B fractional dose (1/5th dose)
Group 2: RTS,S/AS01E Fractional dose group Month 0 and Month 1will receive a double dose of RTS,S/AS01E full dose Month 2 will receive a double dose of RTS,S/AS01E fractional dose (1/5th dose)
Group 3: RTS,S/AS01E Full dose group Month 0, Month 1 and Month 2 will receive RTS,S/AS01E full dose
Group 4: RTS,S/AS01E + DHA-PIP+PQ Full dose group Month 0, Month 1 and Month 2 will receive RTS,S/AS01E full dose + DHA-PIP+PQ
Group 5: RTS,S/AS01E Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01E full dose Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose)
Group 6: RTS,S/AS01E + DHA-PIP+PQ Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01E full dose + DHA-PIP+PQ Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ
Group 7: RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group Month 0 will receive RTS,S/AS01E full dose + DHA-PIP+PQ Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ
RTS,S/AS01B = Standard dose RTS,S/AS01B: 50µg RTS,S + standard dose AS01B RTS,S/AS01E = Standard dose RTS,S/AS01E: 25µg RTS,S + standard dose AS01E DHA-PIP = Dihydroartemisinin/piperaquine PQ = Primaquine
Study participants will be assigned the next available randomization number on the list, and thus will be randomly allocated to Group 1, 2, 3, 4, 5, 6 or 7.
Subsequent vaccination visits (Month 1 / Day 0 and Month 2 / Day 0 visits) Subsequent vaccination visits will be done according to the schedule of procedures. Physical examination will be performed. Any new medical issues or symptoms that have arisen will be assessed. Blood will be collected for parasite microscopy, haemoglobin and biochemistry. Participants with parasitaemia or anaemia will be treated according to national guidelines. Blood will be collected and stored for measurement of antibodies against P. falciparum circumsporozoite (anti-CS antibody) until shipment to the reference laboratory. Urine will be collected from women of child-bearing age for immediate pregnancy test.
Before vaccination, the on-going eligibility of the volunteer will be reviewed. All participants will attend the clinic for vaccination visits, will be observed closely for at least 30 minutes following the administration of each study vaccine, and will receive a paper diary card for recording solicited AEs, as described above. Information will be recorded in the CRF for subsequent vaccination visits.
- Conditions
- Malaria Vaccine
- Being tested
- RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose, RTS,S/AS01E Standard dose, RTS,S/AS01E + DHA-PIP+PQ Standard dose, RTS,S/AS01E Fractional dose
- Keywords
- safety, immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTS,S/AS01B Fractional doseBiological
RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
Double RTS,S/AS01E Fractional doseBiological
A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
RTS,S/AS01E Standard doseBiological
RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
RTS,S/AS01E + DHA-PIP+PQ Standard doseBiological
RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
RTS,S/AS01E Fractional doseBiological
RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
RTS,S/AS01E + DHA-PIP+PQ Fractional doseBiological
RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
RTS,S/AS01E + DHA-PIP+PQ Fractional two-doseBiological
RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | RTS,S/AS01B Fractional dose Receives: Biological: RTS,S/AS01B Fractional dose |
| Group 2 | Experimental | Double RTS,S/AS01E Fractional dose Receives: Biological: Double RTS,S/AS01E Fractional dose |
| Group 3 | Experimental | RTS,S/AS01E Standard dose Receives: Biological: RTS,S/AS01E Standard dose |
| Group 4 | Experimental | RTS,S/AS01E + DHA-PIP+PQ Standard dose Receives: Biological: RTS,S/AS01E + DHA-PIP+PQ Standard dose |
| Group 5 | Experimental | RTS,S/AS01E Fractional dose Receives: Biological: RTS,S/AS01E Fractional dose |
| Group 6 | Experimental | RTS,S/AS01E + DHA-PIP+PQ Fractional dose Receives: Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional dose |
| Group 7 | Experimental | RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose Receives: Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination
Occurrence of serious adverse events (SAEs) from the date of the first vaccination to 29 days after the last vaccination, according to the MedRA classification.
Measured: 29 days after last vaccination
Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination
Occurrence of SAEs during the whole study period, i.e. during a 6 month follow up period from the receipt of first vaccination, according to the MedRA classification.
Measured: 6 months
Number of Participants Who Seroconverted One Month After First Dose.
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Measured: 1 months
Number of Participants Who Seroconverted One Month After the Second Dose.
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Measured: 2 months
Number of Participants Who Seroconverted One Month After the Third Dose.
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Measured: 3 months
Number of Participants Who Seroconverted at Month Six After First Dose.
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Measured: 6 months
Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose.
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).(For group 7)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start4 Jun 2017
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malaria VaccineStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 7 groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz von Seidlein, MD, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992119
- Sponsor's protocol ID
- BAKMAL1605
- Acronym
- RTSS
- Status last verified
- Jul 2019
- First submitted
- 15 Nov 2016
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Evaluation of the Malaria Vaccine, RTS,S/AS01, in Healthy Thai Adults
- ClinicalTrials.gov ID
- NCT02992119
- Acronym / sponsor ID
- RTSS / BAKMAL1605
- Conditions
- Malaria Vaccine
- Keywords
- safety, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 4 Jun 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Targeted malaria elimination (TME), which comprises appropriate case management by village health workers, vector control and mass drug administration, is currently being implemented through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the scale-up of the intervention to the regional level are underway. Based on mathematical modelling, extending the post-TME parasitaemia-free period in the majority of villagers for as short as 200 days will substantially increase the chances of achieving the interruption of malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short term malaria protective effect is stronger than the overall effect assessed over 1-2 years. Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed additional protection.
Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian populations. This trial will generate the required data for the use of this vaccine in Asian populations. For integration with the current TME activities, which provide mass drug administrations at months M0, M1, and M2, it would be most efficient and practical to provide the vaccine at the same intervals. To address a two round intervention (M0, M2) where a three round intervention is not feasible, one study arm will look at the immune response generated by only two doses of vaccine and antimalarial medications. Recent evidence suggests that a vaccination schedule which includes a fractional dose of RTS,S/AS01 (1/5th of the standard dose) could be similarly or more protective than a schedule with three standard full doses, while requiring less vaccine and resources. The trial therefore includes study arms which will assess the safety and immunogenicity of fractional dose schedules.
Each participant will be randomized into one of the following study arms in a ratio of 20:20:30:30:30:30:30, as follows:
- RTS,S/AS01B Fractional dose group (Group 1)
- Double RTS,S /AS01E Fractional dose group (Group 2)
- RTS,S/AS01E Standard dose group (Group 3)
- RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4)
- RTS,S/AS01E Fractional dose group (Group 5)
- RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6)
- RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)
Detailed description
This is a randomized, open-label, single centre, Phase 2 trial of RTS,S/AS01 in healthy Thai adults.
Screening and eligibility assessment (Screening visit)
All potential volunteers will have a screening visit, which may take place up to 30 days prior to enrolment. Once informed consent is given, a screening number will be assigned in sequential order. Screening numbers will be issued consecutively (e.g. A-01, A-02, A-03…).
Enrolment, baseline assessment, regimen allocation, and first vaccination (Month 0 / Day 0 visit; Baseline visit) All inclusion and exclusion criteria will be checked before enrolment in the study. Physical examination will be performed. Any new medical issues or symptoms that have arisen will be assessed. Blood will be collected for baseline parasite microscopy, haemoglobin and biochemistry. Participants with parasitaemia or anaemia will be treated according to national guidelines. Blood will be collected and stored for measurement of antibodies against P. falciparum circumsporozoite (anti-CS antibody) until shipment to the reference laboratory. Urine will be collected from women of child-bearing age for immediate pregnancy test.
If all inclusion criteria are fulfilled and none of the exclusion criteria apply, the patient will be enrolled into the study and a CRF specific to each participant completed. Regimen allocation and administration of the vaccine(s) will be on Day 0. The randomization lists will be prepared by MORU.
Randomization numbers will be generated in blocks, for the 7 intervention arms in a ratio of 20:20:30:30:30:30:30, as follows:
Each participant will be randomized into one of the following study arms Group 1: RTS,S/AS01B Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01B full dose Month 2 will receive RTS,S/AS01B fractional dose (1/5th dose)
Group 2: RTS,S/AS01E Fractional dose group Month 0 and Month 1will receive a double dose of RTS,S/AS01E full dose Month 2 will receive a double dose of RTS,S/AS01E fractional dose (1/5th dose)
Group 3: RTS,S/AS01E Full dose group Month 0, Month 1 and Month 2 will receive RTS,S/AS01E full dose
Group 4: RTS,S/AS01E + DHA-PIP+PQ Full dose group Month 0, Month 1 and Month 2 will receive RTS,S/AS01E full dose + DHA-PIP+PQ
Group 5: RTS,S/AS01E Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01E full dose Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose)
Group 6: RTS,S/AS01E + DHA-PIP+PQ Fractional dose group Month 0 and Month 1 will receive RTS,S/AS01E full dose + DHA-PIP+PQ Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ
Group 7: RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group Month 0 will receive RTS,S/AS01E full dose + DHA-PIP+PQ Month 2 will receive RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ
RTS,S/AS01B = Standard dose RTS,S/AS01B: 50µg RTS,S + standard dose AS01B RTS,S/AS01E = Standard dose RTS,S/AS01E: 25µg RTS,S + standard dose AS01E DHA-PIP = Dihydroartemisinin/piperaquine PQ = Primaquine
Study participants will be assigned the next available randomization number on the list, and thus will be randomly allocated to Group 1, 2, 3, 4, 5, 6 or 7.
Subsequent vaccination visits (Month 1 / Day 0 and Month 2 / Day 0 visits) Subsequent vaccination visits will be done according to the schedule of procedures. Physical examination will be performed. Any new medical issues or symptoms that have arisen will be assessed. Blood will be collected for parasite microscopy, haemoglobin and biochemistry. Participants with parasitaemia or anaemia will be treated according to national guidelines. Blood will be collected and stored for measurement of antibodies against P. falciparum circumsporozoite (anti-CS antibody) until shipment to the reference laboratory. Urine will be collected from women of child-bearing age for immediate pregnancy test.
Before vaccination, the on-going eligibility of the volunteer will be reviewed. All participants will attend the clinic for vaccination visits, will be observed closely for at least 30 minutes following the administration of each study vaccine, and will receive a paper diary card for recording solicited AEs, as described above. Information will be recorded in the CRF for subsequent vaccination visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Randomized 7 groups
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: RTS,S/AS01B Fractional doseRTS,S/AS01B Fractional dose |
| Group 2 | Experimental | Biological: Double RTS,S/AS01E Fractional doseDouble RTS,S/AS01E Fractional dose |
| Group 3 | Experimental | Biological: RTS,S/AS01E Standard doseRTS,S/AS01E Standard dose |
| Group 4 | Experimental | Biological: RTS,S/AS01E + DHA-PIP+PQ Standard doseRTS,S/AS01E + DHA-PIP+PQ Standard dose |
| Group 5 | Experimental | Biological: RTS,S/AS01E Fractional doseRTS,S/AS01E Fractional dose |
| Group 6 | Experimental | Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional doseRTS,S/AS01E + DHA-PIP+PQ Fractional dose |
| Group 7 | Experimental | Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional two-doseRTS,S/AS01E + DHA-PIP+PQ Fractional two-dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant is a healthy male or non-pregnant female, aged 18 to 55 years (inclusive), of Thai origin.
- Participant is willing and able to give informed consent to participate in the trial
- Able, in the investigators opinion, and willing to comply with the study requirements and follow-up.
Key exclusion criteria (22 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition).
- Hepatitis B surface antigen (HBsAg) detected in serum.
- Screening ECG demonstrates a QTc interval ≥ 450 ms
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
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 |
|---|---|---|
| RTS,S/AS01B Fractional doseRTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2. | Biological | Group 1 |
| Double RTS,S/AS01E Fractional doseA double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2. | Biological | Group 2 |
| RTS,S/AS01E Standard doseRTS,S/AS01E standard dose at Month 0, Month 1 and Month 2. | Biological | Group 3 |
| RTS,S/AS01E + DHA-PIP+PQ Standard doseRTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2 | Biological | Group 4 |
| RTS,S/AS01E Fractional doseRTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2. | Biological | Group 5 |
| RTS,S/AS01E + DHA-PIP+PQ Fractional doseRTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2. | Biological | Group 6 |
| RTS,S/AS01E + DHA-PIP+PQ Fractional two-doseRTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2 | Biological | Group 7 |
Primary outcome
Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination
Time frame: 29 days after last vaccination
Occurrence of serious adverse events (SAEs) from the date of the first vaccination to 29 days after the last vaccination, according to the MedRA classification.
Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination
Time frame: 6 months
Occurrence of SAEs during the whole study period, i.e. during a 6 month follow up period from the receipt of first vaccination, according to the MedRA classification.
Number of Participants Who Seroconverted One Month After First Dose.
Time frame: 1 months
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Number of Participants Who Seroconverted One Month After the Second Dose.
Time frame: 2 months
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Number of Participants Who Seroconverted One Month After the Third Dose.
Time frame: 3 months
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Number of Participants Who Seroconverted at Month Six After First Dose.
Time frame: 6 months
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).
Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose.
Time frame: 2 months
The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).(For group 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Lorenz von Seidlein, MD principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose and RTS,S/AS01E Standard dose in people with Malaria Vaccine, run by University of Oxford at 1 site in Thailand.
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 3 inclusion and 22 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 31 Mar 2022. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination (time frame: 29 days after last vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.