Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2018/02/zika-scan-feb-27-2018
Zika Scan for Feb 27, 2018
Zika testing challenges; Phase 1 Zika vaccine trial
Filed Under:
Zika
[h=3]Study highlights shortcomings of Zika testing[/h] A report on two babies born in the Brownsville, Tex., area with congenital Zika infections showed that testing on their mothers during pregnancy and lab tests on babies don't always match up. Researchers from Driscoll Children's Hospital in Corpus Christi, Tex., where both babies were evaluated and treated, described their findings yesterday in Emerging Infectious Diseases.
The two cases were among 18 possible cases of Zika infection in pregnant women that were identified after enhanced testing and screening began in the Brownsville area in the wake of the first confirmed local Zika infection in November 2016. Both of the babies were born to mothers who had spent time in Matamoros, Mexico, during their pregnancies. One spent the first 4 months of her pregnancy in the city, and the other traveled there weekly during early pregnancy.
In both babies, microcephaly was detected during prenatal ultrasound, with findings confirmed after birth.
For the first baby's mother, probable filovirus infection wasn't found on lab testing until the third trimester, and the researchers said earlier immunoglobulin M (IgM) screening at 28 weeks' gestation might have shown a false-negative result. After birth, however, a blood test on her baby was positive for Zika IgM, and tests on the placenta were positive for Zika, confirming the infection in the mother.
In the second case-patient, the mother tested positive for Zika virus infection at 23 weeks, but blood tests on samples from her baby were negative, despite severe congenital Zika features.
The team said the findings for the two case-patients underscore the complexity and challenges of screening and testing for congenital Zika virus infection, as well as the importance of clinical findings and epidemiologic history.
Feb 26 Emerg Infect Dis study
[h=3]Emergent, Valneva announce launch of phase 1 Zika vaccine trial[/h] Emergent BioSolutions and Paris-based Valneva yesterday announced the launch of a phase 1 clinical trial to gauge the safety and immunogenicity of VLA1601, an inactivated Zika vaccine candidate that was developed based on Valneva's Japanese encephalitis vaccine platform.
In a statement, the companies said the study will involve 65 healthy adults and will evaluate two dose levels using two different vaccination schedules. Initial data are expected at the end of 2018 or in early 2019.
After phase 1 data are available, Emergent BioSolutions has the option to continue developing and commercializing the vaccine under a licensing agreement with Valneva for a milestone payment of $6.1 million. Valneva would receive additional milestone payments based on further development, approval, commercialization, product sales, and royalties.
Thomas Lingelbach, president and chief executive officer of Valneva said, "We are delighted that our collaboration with Emergent has resulted in the clinical progression of a very promising vaccine candidate. This vaccine candidate has already demonstrated an excellent preclinical profile comparable to Valneva's licensed Japanese Encephalitis vaccine."
Feb 26 Emergent BioSolutions press release
Zika Scan for Feb 27, 2018
Zika testing challenges; Phase 1 Zika vaccine trial
Filed Under:
Zika
[h=3]Study highlights shortcomings of Zika testing[/h] A report on two babies born in the Brownsville, Tex., area with congenital Zika infections showed that testing on their mothers during pregnancy and lab tests on babies don't always match up. Researchers from Driscoll Children's Hospital in Corpus Christi, Tex., where both babies were evaluated and treated, described their findings yesterday in Emerging Infectious Diseases.
The two cases were among 18 possible cases of Zika infection in pregnant women that were identified after enhanced testing and screening began in the Brownsville area in the wake of the first confirmed local Zika infection in November 2016. Both of the babies were born to mothers who had spent time in Matamoros, Mexico, during their pregnancies. One spent the first 4 months of her pregnancy in the city, and the other traveled there weekly during early pregnancy.
In both babies, microcephaly was detected during prenatal ultrasound, with findings confirmed after birth.
For the first baby's mother, probable filovirus infection wasn't found on lab testing until the third trimester, and the researchers said earlier immunoglobulin M (IgM) screening at 28 weeks' gestation might have shown a false-negative result. After birth, however, a blood test on her baby was positive for Zika IgM, and tests on the placenta were positive for Zika, confirming the infection in the mother.
In the second case-patient, the mother tested positive for Zika virus infection at 23 weeks, but blood tests on samples from her baby were negative, despite severe congenital Zika features.
The team said the findings for the two case-patients underscore the complexity and challenges of screening and testing for congenital Zika virus infection, as well as the importance of clinical findings and epidemiologic history.
Feb 26 Emerg Infect Dis study
[h=3]Emergent, Valneva announce launch of phase 1 Zika vaccine trial[/h] Emergent BioSolutions and Paris-based Valneva yesterday announced the launch of a phase 1 clinical trial to gauge the safety and immunogenicity of VLA1601, an inactivated Zika vaccine candidate that was developed based on Valneva's Japanese encephalitis vaccine platform.
In a statement, the companies said the study will involve 65 healthy adults and will evaluate two dose levels using two different vaccination schedules. Initial data are expected at the end of 2018 or in early 2019.
After phase 1 data are available, Emergent BioSolutions has the option to continue developing and commercializing the vaccine under a licensing agreement with Valneva for a milestone payment of $6.1 million. Valneva would receive additional milestone payments based on further development, approval, commercialization, product sales, and royalties.
Thomas Lingelbach, president and chief executive officer of Valneva said, "We are delighted that our collaboration with Emergent has resulted in the clinical progression of a very promising vaccine candidate. This vaccine candidate has already demonstrated an excellent preclinical profile comparable to Valneva's licensed Japanese Encephalitis vaccine."
Feb 26 Emergent BioSolutions press release