The

n e w e ng l a n d j o u r na l

the value of American Sign Language (ASL). ASL is a recognized, widely taught language that has enabled deaf people to communicate and create a sense of community and culture, thereby defying the stereotypical notion of isolated deaf people. In addition, Bauman and colleagues affirm that the use of vision is as effective as the use of hearing for access to the world.2 Cochlear implants are not a miracle cure for all. To counteract the possibility of limited spoken language development, a fruitful approach not mentioned in the article is that of exposing infants and children to both spoken and signed languages. Leigh presents research on the advantages of exposure to bilingual and bicultural environments, including positive psychological adjustment, for cochlearimplant users.3 Being bilingual enhances their opportunity to succeed in any situation, allows access to diverse deaf and hearing environments, and minimizes the potential for marginalization. James Huang, M.D. Unity Health Care Washington, DC [email protected]

Irene W. Leigh, Ph.D. Lauri Rush, Psy.D.

of

m e dic i n e

The author replies: I am grateful to Huang et al. for their commentary. Rather than presenting cochlear implants as a panacea, my article clearly outlined their limitations. If competence in spoken language is the goal, then exposure to spoken communication in preference to ASL becomes a necessity.1 The plea for a bilingual approach is wholly impractical, because more than 95% of deaf children are born to hearing parents who have no proficiency in sign language — hence, these parents are powerless to transfer fluency in this language. Signed communication may benefit implant recipients who do not have sufficient competence in spoken language and may provide the only viable access to cognitive, social, and language development. The suggestion that the use of vision is as effective as hearing in obtaining access to the world is simply untenable — nature has provided both senses to offer complementary sensory inputs about our world, and to argue the supremacy of one sense over the other seems superfluous. Cochlear implants may be no panacea, but they offer choice and unprecedented opportunity to deaf people. Gerard O’Donoghue, F.R.C.S.

Gallaudet University Washington, DC No potential conflict of interest relevant to this letter was reported. 1. O’Donoghue G. Cochlear implants — science, serendipity,

and success. N Engl J Med 2013;369:1190-3.

2. Bauman H-DL, ed. Open your eyes: deaf studies talking.

Minneapolis: University of Minnesota Press, 2008. 3. Leigh IW. A lens on deaf identities. New York: Oxford University Press, 2009.

Nottingham Hearing Biomedical Research Unit Nottingham, United Kingdom Since publication of his article, the author reports no further potential conflict of interest. 1. Kral A, O’Donoghue GM. Profound deafness in childhood.

N Engl J Med 2010;363:1438-50.

DOI: 10.1056/NEJMc1313728

DOI: 10.1056/NEJMc1313728

A Recombinant Viruslike Particle Influenza A (H7N9) Vaccine To the Editor: Avian-origin influenza A (H7N9) viruses emerged as human pathogens in China in 2013 and have caused 137 cases and 45 deaths to date.1 These viruses have acquired mutations that could facilitate infection in mammals,2 which could pose a pandemic threat if the viruses become readily transmissible in humans. Vaccines are a key defense against pandemics, but candidate vaccines featuring H7 hemagglutinins (HA) have been poorly immunogenic.3 We have previously described the development, manufacture, and efficacy in mice of an 2564

A/Anhui/1/13 (H7N9) viruslike particle (VLP) vaccine produced in insect cells with the use of recombinant baculovirus. This vaccine combines the HA and neuraminidase (NA) of A/Anhui/1/13 with the matrix 1 protein (M1) of A/Indonesia/ 5/05.4,5 We enrolled 284 adults (≥18 years of age) in a randomized, observer-blinded, placebo-controlled clinical trial of this vaccine; all the participants provided written informed consent. The trial was approved by the Bellberry Human Research Ethics Committee in Adelaide, Australia

n engl j med 369;26 nejm.org december 26, 2013

The New England Journal of Medicine Downloaded from nejm.org at STOCKHOLMS UNIVERSTITETSBIBL on August 10, 2015. For personal use only. No other uses without permission. Copyright © 2013 Massachusetts Medical Society. All rights reserved.

0

Participants with seroconversion — % (95% CI)‡

n engl j med 369;26 nejm.org december 26, 2013

5.7 (0.7–19.7)

Participants with seroresponse — % (95% CI)§

2.9 (0.1–14.9)

Participants with seroresponse — % (95% CI)§

57.1 (39.4–73.7)

372 (286–483)

8.6 (1.8–23.1)

266 (211–336)

216 (175–268)

5.7 (0.7–19.2)

6.8 (5.2–9.0)

2.9 (0.1–14.9)

5.6 (4.5–6.8)

0

5.1 (4.9–5.3)

35

15 µg

9.6 (6.2–15.0)

3.1 (0.1–16.2)

5.7 (4.7–6.8)

0

5

32

45 µg

71.9 (53.3–86.3)

468 (338–648)

21.9 (9.3–30.0)

310 (236–409)

167 (140–199)

15.6 (5.3–32.8)

Vaccine with No Adjuvant

91.9 (78.1–98.3)

880 (679–1142)

21.6 (9.8–38.2)

331 (270–406)

196 (157–245)

64.9 (47.5–79.8)

37.1 (27.9–49.4)

0

5.4 (4.9–5.9)

0

5

37

5 µg 38

15 µg

92.1 (78.6–98.3)

873 (646–1179)

44.7 (28.6–61.7)

405 (305–336)

189 (150–238)

36.8 (21.8–54.0)

22.7 (18.1–32.7)

2.6 (0.1–13.8)

5.8 (5.0–6.7)

0

5.1 (4.9–5.3)

30 ISCO Units

97.2 (85.5–99.9)

1472 (1091–1905)

36.1 (20.8–53.8)

425 (305–593)

197 (155–250)

80.6 (64.0–91.8)

64.3 (48.5–85.3)

0

6.7 (5.8–7.7)

0

0

5

34

15 µg

97.1 (84.7–99.9)

959 (712–1294)

35.3 (19.8–53.5)

320 (245–418)

158 (133–189)

64.7 (46.5–80.3)

37.1 (28.4–48.5)

0

5.4 (4.9–6.0)

60 ISCO Units

5.2 (4.9–5.5)

36

5 µg

Vaccine with Adjuvant

* HAI denotes hemagglutination inhibition, ISCO ISCOMATRIX, and NAI neuraminidase inhibition. † Groups that had titers below the limit of detection at baseline were assigned an arbitrary value of 5 by convention. ‡ Seroconversion was defined as an increase by a factor of 4 or more in a reciprocal titer of 10 or more or an increase from a level below the limit of detection (

A recombinant viruslike particle influenza A (H7N9) vaccine.

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