The Lancet – Dec 12, 2015

The Lancet
Dec 12, 2015 Volume 386 Number 10011 p2365-2444 e56-e60
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Remembering the right to health
The Lancet
Summary
Dec 10 marks Human Rights Day. This year, the day is devoted to the launch of a year-long UN campaign to celebrate the 50th anniversary of two landmark international covenants on human rights: the International Covenant on Economic, Social and Cultural Rights and the International Covenant on Civil and Political Rights, which were adopted by the UN General Assembly on Dec 16, 1966.

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Comment
Women’s, children’s, and adolescents’ health needs universal health coverage
Robin Gorna, Nicole Klingen, Kunio Senga, Agnes Soucat, Keizo Takemi
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A worldwide shift in polio vaccines for routine immunisation
Julie R Garon, Walter A Orenstein
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Articles
Immunogenicity of a new routine vaccination schedule for global poliomyelitis prevention: an open-label, randomised controlled trial
Roland W Sutter, Sunil Bahl, Jagadish M Deshpande, Harish Verma, Mohammad Ahmad, P Venugopal, J Venkateswara Rao, Sharad Agarkhedkar, Sanjay K Lalwani, Abhishek Kunwar, Raman Sethi, Marina Takane, Lalitendu Mohanty, Arani Chatterjee, T Jacob John, Hamid Jafari, R Bruce Aylward
Summary
Background
Polio eradication needs a new routine immunisation schedule—three or four doses of bivalent type 1 and type 3 oral poliovirus vaccine (bOPV) and one dose of inactivated poliovirus vaccine (IPV), but no immunogenicity data are available for this schedule. We aimed to assess immunogenicity of this vaccine schedule.
Methods
We did an open-label, randomised controlled trial in four centres in India. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of five groups: trivalent OPV (tOPV); tOPV plus IPV; bOPV; bOPV plus IPV; or bOPV plus two doses of IPV (2IPV). The key eligibility criteria were: full-term birth (≥37 weeks of gestation); birthweight ≥2·5 kg; and Apgar score of 9 or more. OPV was administered at birth, 6 weeks, 10 weeks, and 14 weeks; IPV was administered intramuscularly at 14 weeks. The primary study objective was to investigate immunogenicity of the new vaccine schedule, assessed by seroconversion against poliovirus types 1, 2, and 3 between birth and 18 weeks in the per-protocol population (all participants with valid serology results on cord blood and at 18 weeks). Neutralisation assays tested cord blood and sera collected at 14 weeks, 18 weeks, 19 weeks, and 22 weeks by investigators masked to group allocation. This trial was registered with the India Clinical Trials Registry, number CTRI/2013/06/003722.
Findings
Of 900 newborn babies enrolled between June 13 and Aug 29, 2013, 782 (87%) completed the per-protocol requirements. Between birth and age 18 weeks, seroconversion against poliovirus type 1 in the tOPV group occurred in 162 of 163 (99·4%, 95% CI 96·6–100), in 150 (98·0%, 94·4–99·6) of 153 in the tOPV plus IPV group, in 153 (98·7%, 95·4–99·8) of 155 in the bOPV group, in 155 (99·4%, 96·5–100) of 156 in the bOPV plus IPV group, and in 154 (99·4%, 96·5–100) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 2 occurred in 157 (96·3%, 92·2–98·6) of 163 in the tOPV group, 153 (100%, 97·6–100·0) of 153 in the tOPV plus IPV group, 29 (18·7%, 12·9–25·7) of 155 in the bOPV group, 107 (68·6%, 60·7–75·8) of 156 in the bOPV plus IPV group, and in 121 (78·1%, 70·7–84·3) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 3 was achieved in 147 (90·2%, 84·5–94·3) of 163 in the tOPV group, 152 (99·3%, 96·4–100) of 153 in the tOPV plus IPV group, 151 (97·4%, 93·5–99·3) of 155 in the bOPV group, 155 (99·4%, 96·5–100) of 156 in the bOPV plus IPV group, and 153 (98·7%, 95·4–99·8) of 155 in the bOPV plus 2IPV group. Superiority was achieved for vaccine regimens including IPV against poliovirus type 3 compared with those not including IPV (tOPV plus IPV vs tOPV alone, p=0·0008; and bOPV plus IPV vs bOPV alone, p=0·0153). 12 serious adverse events occurred (six in the tOPV group, one in the tOPV plus IPV group, three in the bOPV group, zero in the bOPV plus IPV group, and two in the bOPV plus 2IPV group), none of which was attributed to the trial intervention.
Interpretation
The new vaccination schedule improves immunogenicity against polioviruses, especially against poliovirus type 3.
Funding
WHO, through a grant from Rotary International ( grant number 59735 ).

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Review
Assuring health coverage for all in India
Vikram Patel, Rachana Parikh, Sunil Nandraj, Priya Balasubramaniam, Kavita Narayan, Vinod K Paul, A K Shiva Kumar, Mirai Chatterjee, K Srinath Reddy

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Health Policy
How much donor financing for health is channelled to global versus country-specific aid functions?
Marco Schäferhoff, Sara Fewer, Jessica Kraus, Emil Richter, Lawrence H Summers, Jesper Sundewall, Gavin Yamey, Dean T Jamison

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Viewpoint
The health gap: the challenge of an unequal world
Michael Marmot