| Issaka Sagara, Issaka Zongo, Matthew Cairns, Rakiswendé Serge Yerbanga, Almahamoudou Mahamar, Frédéric Nikièma, Amadou Tapily, Frédéric Sompougdou, Modibo Diarra, Charles Zoungrana, Djibrilla Issiaka, Alassane Haro, Koualy Sanogo, Abdoul Aziz Sienou, Mahamadou Kaya, Seydou Traore, Ismaila Thera, Kalifa Diarra, Amagana Dolo, Irene Kuepfer, Paul Snell, Paul Milligan, Christian Ockenhouse, Opokua Ofori-Anyinam, Halidou Tinto, Abdoulaye Djimde, Jean Bosco Ouedraogo, Alassane Dicko, Daniel Chandramohan, Brian Greenwood The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine (Journal Article) In: Clinical Infectious Diseases, vol. 75, iss. 4, pp. 613-622, 2022, ISSN: 1058-4838. @article{Sagara2022,
title = {The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine},
author = {Issaka Sagara and Issaka Zongo and Matthew Cairns and Rakiswend\'{e} Serge Yerbanga and Almahamoudou Mahamar and Fr\'{e}d\'{e}ric Niki\`{e}ma and Amadou Tapily and Fr\'{e}d\'{e}ric Sompougdou and Modibo Diarra and Charles Zoungrana and Djibrilla Issiaka and Alassane Haro and Koualy Sanogo and Abdoul Aziz Sienou and Mahamadou Kaya and Seydou Traore and Ismaila Thera and Kalifa Diarra and Amagana Dolo and Irene Kuepfer and Paul Snell and Paul Milligan and Christian Ockenhouse and Opokua Ofori-Anyinam and Halidou Tinto and Abdoulaye Djimde and Jean Bosco Ouedraogo and Alassane Dicko and Daniel Chandramohan and Brian Greenwood},
url = {https://academic.oup.com/cid/article/75/4/613/6459764},
doi = {10.1093/cid/ciab1017},
issn = {1058-4838},
year = {2022},
date = {2022-01-01},
journal = {Clinical Infectious Diseases},
volume = {75},
issue = {4},
pages = {613-622},
abstract = {BACKGROUND A trial in African children showed that combining seasonal vaccination with the RTS,S/AS01E vaccine with seasonal malaria chemoprevention reduced the incidence of uncomplicated and severe malaria compared with either intervention given alone. Here, we report on the anti-circumsporozoite antibody response to seasonal RTS,S/AS01E vaccination in children in this trial. METHODS Sera from a randomly selected subset of children collected before and 1 month after 3 priming doses of RTS,S/AS01E and before and 1 month after 2 seasonal booster doses were tested for anti-circumsporozoite antibodies using enzyme-linked immunosorbent assay. The association between post-vaccination antibody titer and incidence of malaria was explored. RESULTS A strong anti-circumsporozoite antibody response to 3 priming doses of RTS,S/AS01E was seen (geometric mean titer, 368.9 enzyme-linked immunosorbent assay units/mL), but titers fell prior to the first booster dose. A strong antibody response to an annual, pre-malaria transmission season booster dose was observed, but this was lower than after the primary vaccination series and lower after the second than after the first booster dose (ratio of geometric mean rise, 0.66; 95% confidence interval [CI], .57-.77). Children whose antibody response was in the upper tercile post-vaccination had a lower incidence of malaria during the following year than children in the lowest tercile (hazard ratio, 0.43; 95% CI, .28-.66). CONCLUSIONS Seasonal vaccination with RTS,S/AS01E induced a strong booster antibody response that was lower after the second than after the first booster dose. The diminished antibody response to the second booster dose was not associated with diminished efficacy. CLINICAL TRIALS REGISTRATION NCT03143218.},
keywords = {anti-circumsporozoite antibody, Burkina Faso, Mali, RTS, S/AS01E vaccine, seasonal vaccination},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND A trial in African children showed that combining seasonal vaccination with the RTS,S/AS01E vaccine with seasonal malaria chemoprevention reduced the incidence of uncomplicated and severe malaria compared with either intervention given alone. Here, we report on the anti-circumsporozoite antibody response to seasonal RTS,S/AS01E vaccination in children in this trial. METHODS Sera from a randomly selected subset of children collected before and 1 month after 3 priming doses of RTS,S/AS01E and before and 1 month after 2 seasonal booster doses were tested for anti-circumsporozoite antibodies using enzyme-linked immunosorbent assay. The association between post-vaccination antibody titer and incidence of malaria was explored. RESULTS A strong anti-circumsporozoite antibody response to 3 priming doses of RTS,S/AS01E was seen (geometric mean titer, 368.9 enzyme-linked immunosorbent assay units/mL), but titers fell prior to the first booster dose. A strong antibody response to an annual, pre-malaria transmission season booster dose was observed, but this was lower than after the primary vaccination series and lower after the second than after the first booster dose (ratio of geometric mean rise, 0.66; 95% confidence interval [CI], .57-.77). Children whose antibody response was in the upper tercile post-vaccination had a lower incidence of malaria during the following year than children in the lowest tercile (hazard ratio, 0.43; 95% CI, .28-.66). CONCLUSIONS Seasonal vaccination with RTS,S/AS01E induced a strong booster antibody response that was lower after the second than after the first booster dose. The diminished antibody response to the second booster dose was not associated with diminished efficacy. CLINICAL TRIALS REGISTRATION NCT03143218. |
| Matthew Cairns, Amadou Barry, Issaka Zongo, Issaka Sagara, Serge R. Yerbanga, Modibo Diarra, Charles Zoungrana, Djibrilla Issiaka, Abdoul Aziz Sienou, Amadou Tapily, Koualy Sanogo, Mahamadou Kaya, Seydou Traore, Kalifa Diarra, Hama Yalcouye, Youssoufa Sidibe, Alassane Haro, Ismaila Thera, Paul Snell, Jane Grant, Halidou Tinto, Paul Milligan, Daniel Chandramohan, Brian Greenwood, Alassane Dicko, Jean Bosco Ouedraogo The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone (Journal Article) In: BMC Medicine, vol. 20, iss. 1, pp. 352, 2022, ISSN: 1741-7015. @article{Cairns2022,
title = {The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone},
author = {Matthew Cairns and Amadou Barry and Issaka Zongo and Issaka Sagara and Serge R. Yerbanga and Modibo Diarra and Charles Zoungrana and Djibrilla Issiaka and Abdoul Aziz Sienou and Amadou Tapily and Koualy Sanogo and Mahamadou Kaya and Seydou Traore and Kalifa Diarra and Hama Yalcouye and Youssoufa Sidibe and Alassane Haro and Ismaila Thera and Paul Snell and Jane Grant and Halidou Tinto and Paul Milligan and Daniel Chandramohan and Brian Greenwood and Alassane Dicko and Jean Bosco Ouedraogo},
url = {https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02536-5},
doi = {10.1186/s12916-022-02536-5},
issn = {1741-7015},
year = {2022},
date = {2022-01-01},
journal = {BMC Medicine},
volume = {20},
issue = {1},
pages = {352},
abstract = {BACKGROUND A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01E malaria vaccine (primary series and two seasonal boosters) and seasonal malaria chemoprevention (four monthly cycles per year) was markedly more effective than either intervention given alone in preventing clinical malaria, severe malaria, and deaths from malaria. METHODS In order to help optimise the timing of these two interventions, trial data were reanalysed to estimate the duration of protection against clinical malaria provided by RTS,S/AS01E when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01E with the group who received SMC alone. The duration of protection from SMC was also estimated comparing the combined intervention group with the group who received RTS,S/AS01E alone. Three methods were used: Piecewise Cox regression, Flexible parametric survival models and Smoothed Schoenfeld residuals from Cox models, stratifying on the study area and using robust standard errors to control for within-child clustering of multiple episodes. RESULTS The overall protective efficacy from RTS,S/AS01E over 6 months was at least 60% following the primary series and the two seasonal booster doses and remained at a high level over the full malaria transmission season. Beyond 6 months, protective efficacy appeared to wane more rapidly, but the uncertainty around the estimates increases due to the lower number of cases during this period (coinciding with the onset of the dry season). Protection from SMC exceeded 90% in the first 2-3 weeks post-administration after several cycles, but was not 100%, even immediately post-administration. Efficacy begins to decline from approximately day 21 and then declines more sharply after day 28, indicating the importance of preserving the delivery interval for SMC cycles at a maximum of four weeks. CONCLUSIONS The efficacy of both interventions was highest immediately post-administration. Understanding differences between these interventions in their peak efficacy and how rapidly efficacy declines over time will help to optimise the scheduling of SMC, malaria vaccination and the combination in areas of seasonal transmission with differing epidemiology, and using different vaccine delivery systems. TRIAL REGISTRATION The RTS,S-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT03143218.},
keywords = {Malaria, Malaria vaccination, Plasmodium falciparum, RTS, S/AS01E, seasonal malaria chemoprevention},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01E malaria vaccine (primary series and two seasonal boosters) and seasonal malaria chemoprevention (four monthly cycles per year) was markedly more effective than either intervention given alone in preventing clinical malaria, severe malaria, and deaths from malaria. METHODS In order to help optimise the timing of these two interventions, trial data were reanalysed to estimate the duration of protection against clinical malaria provided by RTS,S/AS01E when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01E with the group who received SMC alone. The duration of protection from SMC was also estimated comparing the combined intervention group with the group who received RTS,S/AS01E alone. Three methods were used: Piecewise Cox regression, Flexible parametric survival models and Smoothed Schoenfeld residuals from Cox models, stratifying on the study area and using robust standard errors to control for within-child clustering of multiple episodes. RESULTS The overall protective efficacy from RTS,S/AS01E over 6 months was at least 60% following the primary series and the two seasonal booster doses and remained at a high level over the full malaria transmission season. Beyond 6 months, protective efficacy appeared to wane more rapidly, but the uncertainty around the estimates increases due to the lower number of cases during this period (coinciding with the onset of the dry season). Protection from SMC exceeded 90% in the first 2-3 weeks post-administration after several cycles, but was not 100%, even immediately post-administration. Efficacy begins to decline from approximately day 21 and then declines more sharply after day 28, indicating the importance of preserving the delivery interval for SMC cycles at a maximum of four weeks. CONCLUSIONS The efficacy of both interventions was highest immediately post-administration. Understanding differences between these interventions in their peak efficacy and how rapidly efficacy declines over time will help to optimise the scheduling of SMC, malaria vaccination and the combination in areas of seasonal transmission with differing epidemiology, and using different vaccine delivery systems. TRIAL REGISTRATION The RTS,S-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT03143218. |
| Innocent Valéa, Samuel Adjei, Effua Usuf, Ousmane Traore, Daniel Ansong, Halidou Tinto, Harry Owusu Boateng, Amanda Leach, Athanase Mwinessobaonfou Some, Patrick Buabeng, Johan Vekemans, Louis Arnaud Nana, Amos Kotey, Pascale Vandoolaeghe, Florence Ouedraogo, David Sambian, Marc Lievens, Marc Christian Tahita, Theresa Rettig, Erik Jongert, Palpouguini Lompo, Ali Idriss, Dorota Borys, Sayouba Ouedraogo, Frank Prempeh, Md Ahsan Habib, Lode Schuerman, Hermann Sorgho, Tsiri Agbenyega Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial (Journal Article) In: Hum. Vaccin. Immunother., vol. 14, no. 6, pp. 1489–1500, 2018, ISSN: 2164-554X 2164-5515. @article{Valea2018-yp,
title = {Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial},
author = {Innocent Val\'{e}a and Samuel Adjei and Effua Usuf and Ousmane Traore and Daniel Ansong and Halidou Tinto and Harry Owusu Boateng and Amanda Leach and Athanase Mwinessobaonfou Some and Patrick Buabeng and Johan Vekemans and Louis Arnaud Nana and Amos Kotey and Pascale Vandoolaeghe and Florence Ouedraogo and David Sambian and Marc Lievens and Marc Christian Tahita and Theresa Rettig and Erik Jongert and Palpouguini Lompo and Ali Idriss and Dorota Borys and Sayouba Ouedraogo and Frank Prempeh and Md Ahsan Habib and Lode Schuerman and Hermann Sorgho and Tsiri Agbenyega},
doi = {10.1080/21645515.2018.1442996},
issn = {2164-554X 2164-5515},
year = {2018},
date = {2018-06-01},
urldate = {2018-06-01},
journal = {Hum. Vaccin. Immunother.},
volume = {14},
number = {6},
pages = {1489--1500},
abstract = {The RTS,S/AS01 malaria vaccine (Mosquirix) reduces the incidence
of Plasmodium falciparum malaria and is intended for routine
administration to infants in Sub-Saharan Africa. We evaluated the
immunogenicity and safety of 10-valent pneumococcal non-typeable
Haemophilus influenzae protein D conjugate vaccine (PHiD-CV;
Synflorix) and human rotavirus vaccine (HRV; Rotarix) when
co-administered with RTS,S/AS01 ( www.clinicaltrials.gov
NCT01345240) in African infants. 705 healthy infants aged 8-12
weeks were randomized to receive three doses of either RTS,S/AS01
or licensed hepatitis B (HBV; Engerix B) vaccine (control)
co-administered with diphtheria-tetanus-acellular
pertussis-Haemophilus influenzae type-b-conjugate vaccine
(DTaP/Hib) and trivalent oral poliovirus vaccine at 8-12-16 weeks
of age, because DTaP/Hib was not indicated before 8 weeks of age.
The vaccination schedule can still be considered broadly
applicable because it was within the age range recommended for
EPI vaccination. PHiD-CV or HRV were either administered together
with the study vaccines, or after a 2-week interval. Booster
doses of PHiD-CV and DTaP/Hib were administered at age 18 months.
Non-inferiority of anti-HBV surface antigen antibody
seroprotection rates following co-administration with RTS,S/AS01
was demonstrated compared to the control group (primary
objective). Pre-specified non-inferiority criteria were reached
for PHiD-CV (for 9/10 vaccine serotypes), HRV, and aP antigens
co-administered with RTS,S/AS01 as compared to HBV
co-administration (secondary objectives). RTS,S/AS01 induced a
response to circumsporozoite protein in all groups. Pain and low
grade fever were reported more frequently in the PHiD-CV group
co-administered with RTS,S/AS01 than PHiD-CV co-administered with
HBV. No serious adverse events were considered to be
vaccine-related. RTS,S/AS01 co-administered with pediatric
vaccines had an acceptable safety profile. Immune responses to
RTS,S/AS01 and to co-administered PHiD-CV, pertussis antigens and
HRV were satisfactory.},
keywords = {RTS, S; co-administration; hepatitis B; immunogenicity; malaria; plasmodium falciparum; pneumococcal conjugate vaccine; vaccine},
pubstate = {published},
tppubtype = {article}
}
The RTS,S/AS01 malaria vaccine (Mosquirix) reduces the incidence
of Plasmodium falciparum malaria and is intended for routine
administration to infants in Sub-Saharan Africa. We evaluated the
immunogenicity and safety of 10-valent pneumococcal non-typeable
Haemophilus influenzae protein D conjugate vaccine (PHiD-CV;
Synflorix) and human rotavirus vaccine (HRV; Rotarix) when
co-administered with RTS,S/AS01 ( www.clinicaltrials.gov
NCT01345240) in African infants. 705 healthy infants aged 8-12
weeks were randomized to receive three doses of either RTS,S/AS01
or licensed hepatitis B (HBV; Engerix B) vaccine (control)
co-administered with diphtheria-tetanus-acellular
pertussis-Haemophilus influenzae type-b-conjugate vaccine
(DTaP/Hib) and trivalent oral poliovirus vaccine at 8-12-16 weeks
of age, because DTaP/Hib was not indicated before 8 weeks of age.
The vaccination schedule can still be considered broadly
applicable because it was within the age range recommended for
EPI vaccination. PHiD-CV or HRV were either administered together
with the study vaccines, or after a 2-week interval. Booster
doses of PHiD-CV and DTaP/Hib were administered at age 18 months.
Non-inferiority of anti-HBV surface antigen antibody
seroprotection rates following co-administration with RTS,S/AS01
was demonstrated compared to the control group (primary
objective). Pre-specified non-inferiority criteria were reached
for PHiD-CV (for 9/10 vaccine serotypes), HRV, and aP antigens
co-administered with RTS,S/AS01 as compared to HBV
co-administration (secondary objectives). RTS,S/AS01 induced a
response to circumsporozoite protein in all groups. Pain and low
grade fever were reported more frequently in the PHiD-CV group
co-administered with RTS,S/AS01 than PHiD-CV co-administered with
HBV. No serious adverse events were considered to be
vaccine-related. RTS,S/AS01 co-administered with pediatric
vaccines had an acceptable safety profile. Immune responses to
RTS,S/AS01 and to co-administered PHiD-CV, pertussis antigens and
HRV were satisfactory. |